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4 jobs found in greenville, north carolina

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    • greenville, north carolina
    • permanent
    • $65,000 - $70,000 per year
    job summary: This position requires the ability perform established routine and non-routine Quality Assurance tasks with minimal supervision in support of internal non-commercial clients, external clients and/or commercial processes and projects as assigned. The work schedule for this position is Monday through Thursday -- 4:00 pm to 2:30 am. There is potential for Friday scheduling depending on business needs.   location: Greenville, North Carolina job type: Permanent salary: $65,000 - 70,000 per year work hours: 8 to 4 education: Bachelors   responsibilities: Routine Quality Review: Provide timely and careful review of routine laboratory, product development and manufacturing work output to assure the highest standards of quality are met or exceeded and in compliance with regulatory requirements; escalate issues as necessary and partner with operational teams to correct issuesNon-Routine Quality Review: Provide timely and careful review of more complex laboratory, product development and manufacturing work output to assure the highest standards of quality are met or exceeded and in compliance with regulatory requirements. Escalates issues as necessary and partners with operational teams to correct issues.Proactive Operational Support: Develop partnerships with operational teams to provide proactive guidance and direction to assure the quality standards are known and understood from inception to completionQuality Advocacy: Provide broad advocacy for the continued improvement of quality standards and the development and maintenance of a quality culture across the organizationCAPA Remediation: As assigned and under general supervision, participate in the development and implementation of corrective and preventative actions around quality deviancesFollow all regulatory guidelines, cGMP guidelines, EH&S and local regulations as requiredProvide assistance to development, operations, laboratories and validation groups with appropriate quality oversight through review, approval and release of records, reports, and completed packets as assignedProvide real-time support activities for production lines, analytical laboratories and pharmaceutical development operationsEscalate unplanned events and issues, providing immediate notification to QA Supervisor and Manager, supporting and providing guidance to operations, development and laboratory staff as assignedReview Quality documentation including but not limited to review and release of Batch Records, release of equipment, room set up, room clearance, initial documentation of unplanned events as appropriateAssist and support Internal Audit program, assure timely completion of CAPA items as assignedRemain proficient and knowledgeable within respective field of operation in accordance with job responsibility and function, able to troubleshoot process, system, material and technique-related issuesAct as QA representative on project teams, providing Quality guidance and support while working to facilitate lean processes  qualifications: Prior experience with external customersExperience in quality reviews of manufacturing and packaging batch records for bulk and finished packaged product for final disposition of lotsKnowledge of root cause analysis techniques to support manufacturing and packaging investigations/deviations Experience with review / summary Annual Product Reviews (APRs)Attentive to detail, able to recognize critical attributes, steps and functions relating to manufacturing processes and/or laboratory activitiesKnowledgeable of cGMPs and application of good documentation practices within pharmaceutical industryExperience with conducting activities of manufacturing / packaging QA on the floor - Production line clearances, addressing production issues real time, product hold decisionsExperience working in an ERP system - preferably SAP or QADKnowledge of label control operations (sampling, issuance, release processes)Act as QA representative on project teamsExperience writing/reviewing deviations, OOS, CAPAs for approvalExperience revising procedures in an electronic document management system (preferably MasterControl)  skills: Quality Assurance, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: This position requires the ability perform established routine and non-routine Quality Assurance tasks with minimal supervision in support of internal non-commercial clients, external clients and/or commercial processes and projects as assigned. The work schedule for this position is Monday through Thursday -- 4:00 pm to 2:30 am. There is potential for Friday scheduling depending on business needs.   location: Greenville, North Carolina job type: Permanent salary: $65,000 - 70,000 per year work hours: 8 to 4 education: Bachelors   responsibilities: Routine Quality Review: Provide timely and careful review of routine laboratory, product development and manufacturing work output to assure the highest standards of quality are met or exceeded and in compliance with regulatory requirements; escalate issues as necessary and partner with operational teams to correct issuesNon-Routine Quality Review: Provide timely and careful review of more complex laboratory, product development and manufacturing work output to assure the highest standards of quality are met or exceeded and in compliance with regulatory requirements. Escalates issues as necessary and partners with operational teams to correct issues.Proactive Operational Support: Develop partnerships with operational teams to provide proactive guidance and direction to assure the quality standards are known and understood from inception to completionQuality Advocacy: Provide broad advocacy for the continued improvement of quality standards and the development and maintenance of a quality culture across the organizationCAPA Remediation: As assigned and under general supervision, participate in the development and implementation of corrective and preventative actions around quality deviancesFollow all regulatory guidelines, cGMP guidelines, EH&S and local regulations as requiredProvide assistance to development, operations, laboratories and validation groups with appropriate quality oversight through review, approval and release of records, reports, and completed packets as assignedProvide real-time support activities for production lines, analytical laboratories and pharmaceutical development operationsEscalate unplanned events and issues, providing immediate notification to QA Supervisor and Manager, supporting and providing guidance to operations, development and laboratory staff as assignedReview Quality documentation including but not limited to review and release of Batch Records, release of equipment, room set up, room clearance, initial documentation of unplanned events as appropriateAssist and support Internal Audit program, assure timely completion of CAPA items as assignedRemain proficient and knowledgeable within respective field of operation in accordance with job responsibility and function, able to troubleshoot process, system, material and technique-related issuesAct as QA representative on project teams, providing Quality guidance and support while working to facilitate lean processes  qualifications: Prior experience with external customersExperience in quality reviews of manufacturing and packaging batch records for bulk and finished packaged product for final disposition of lotsKnowledge of root cause analysis techniques to support manufacturing and packaging investigations/deviations Experience with review / summary Annual Product Reviews (APRs)Attentive to detail, able to recognize critical attributes, steps and functions relating to manufacturing processes and/or laboratory activitiesKnowledgeable of cGMPs and application of good documentation practices within pharmaceutical industryExperience with conducting activities of manufacturing / packaging QA on the floor - Production line clearances, addressing production issues real time, product hold decisionsExperience working in an ERP system - preferably SAP or QADKnowledge of label control operations (sampling, issuance, release processes)Act as QA representative on project teamsExperience writing/reviewing deviations, OOS, CAPAs for approvalExperience revising procedures in an electronic document management system (preferably MasterControl)  skills: Quality Assurance, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • greenville, north carolina
    • permanent
    • $70,000 - $80,000 per year
    job summary: This position performs routine and non-routine analytical testing in support of pharmaceutical products following all applicable safety, quality, and regulation requirements. This role provides laboratory troubleshooting for a team to assist in the successful and timely execution of laboratory analyses.   location: Greenville, North Carolina job type: Permanent salary: $70,000 - 80,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: Analytical Testing: With limited supervision, perform a broad array of primary and advanced analytical testing methods (wet and dry chemistry) in compliance with all cGMP and regulatory guidelines and ensure the highest standards for efficiency, right first-time measures, and quality standardsClient Service: Support and sometimes participate in the direct interaction with client organizations to assure timely and complete reporting, problem-solving and the highest level of service and responsivenessData Integrity: Ensure integrity of data through accurate transactions, documentation, and tracking of all cGMP activitiesData Interpretation and Problem-Solving: Use appropriate resources (e.g. software) toinvestigate and interpret data in support of recommendations for problem-solving related to methods, instruments and analytical techniques.Process Improvement: Identify and recommend opportunities for improved efficiencies, client service and teamwork within the analytical groupQuality: Ensure the quality of work, products and services as a first priority; comply with or exceed all regulatory and cGMP compliance standards as well as ensure accuracy of analyses as it relates to right first time measuresSafety: Adhere to all workplace safety laws, regulations, standards, and practices and actively advance a culture of safety within his or her team and organization.Independently perform routine and complex testing for chromatographic and spectrophotometric methods (HPLC, GC, UV) of analysis for excipients, new chemical entities and/or drug productsInterpret data and make recommendations to management for improvement or potential concernsCompare laboratory data against specifications, prepare reports, and trend data where applicable to determine if results meet requirementsEnsure proper usage, care, and return of calibration standards including, but not limited to, reference standards, timers, thermometers, and instrumentationEnsure accuracy of testing by following method/standard instructions and adhering to internal SOPs to eliminate the potential for repeat testing, deviations, and investigationsIndependently author standard operating procedures, analytical testing procedures, final submission ready documents, and create document templates for use by junior team membersCreate report templates and/or enter data into established reports/templates or software-based systemsReview routine laboratory experiments for accuracy and provide guidance to junior team members to ensure future complianceIdentify and recommend opportunities for improved efficiencies, internal/external client service and teamwork within the analytical groupServe as a point of contact for laboratory testing support and provide updates to laboratory supervision and/or clientWith supervision, support the scheduling and planning of internal/external client project work to ensure the highest levels of efficiency and quality standards are metSupport the development of a climate of quality within the teams by driving and monitoring quality standards within the teamBecome resident expert in the use of Empower (perform supervisory sign-off for electronic reports) and other software-based systemsServe as a method troubleshooting resource to identify and document critical factors that affect method performance and assist peers in resolving method issues in a timely, cost-effective mannerIndependently perform method evaluation/development/validation and troubleshooting instruments and improvement of processesAssist laboratory management with the preparation and execution of laboratory investigations/deviations and CAPA within the electronic quality system (eQMS)Mentor and train new laboratory team members  qualifications: Analytical Acumen: Skilled in the interpretation and application of data in problem-solving, decision-making, account planning, and activity prioritization.Decision Quality: Considers all relevant factors (analysis, wisdom, experience and judgment) and uses appropriate decision-making criteria and principles.Equipment Operation: Is skilled in the use and trouble-shooting of key equipment important in the delivery of the job.Problem Solving: Build a logical approach to address problems or opportunities or manage the situation at hand by drawing on one's knowledge and experience base and calling on other references and resources as necessary.Quality: Prioritizes and delivers highest levels of quality in work and interactions with customers and team members.Self-Awareness: Self-Aware, open to coaching and self-improvement, agile and decisive in decisions. Is highly effective socially and interpersonally- adept at interpreting social and emotional cures and adapting approach and messaging accordingly.Training Others: Carefully and fully articulates methods and approaches in a way that is understood by using delivery mechanisms that meet the needs of the learner.Written Communication: Conveys ideas and facts in writing in a way that will be understood by composing in a clear, direct, concise and complete manner.  skills: Analytical Chemistry Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: This position performs routine and non-routine analytical testing in support of pharmaceutical products following all applicable safety, quality, and regulation requirements. This role provides laboratory troubleshooting for a team to assist in the successful and timely execution of laboratory analyses.   location: Greenville, North Carolina job type: Permanent salary: $70,000 - 80,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: Analytical Testing: With limited supervision, perform a broad array of primary and advanced analytical testing methods (wet and dry chemistry) in compliance with all cGMP and regulatory guidelines and ensure the highest standards for efficiency, right first-time measures, and quality standardsClient Service: Support and sometimes participate in the direct interaction with client organizations to assure timely and complete reporting, problem-solving and the highest level of service and responsivenessData Integrity: Ensure integrity of data through accurate transactions, documentation, and tracking of all cGMP activitiesData Interpretation and Problem-Solving: Use appropriate resources (e.g. software) toinvestigate and interpret data in support of recommendations for problem-solving related to methods, instruments and analytical techniques.Process Improvement: Identify and recommend opportunities for improved efficiencies, client service and teamwork within the analytical groupQuality: Ensure the quality of work, products and services as a first priority; comply with or exceed all regulatory and cGMP compliance standards as well as ensure accuracy of analyses as it relates to right first time measuresSafety: Adhere to all workplace safety laws, regulations, standards, and practices and actively advance a culture of safety within his or her team and organization.Independently perform routine and complex testing for chromatographic and spectrophotometric methods (HPLC, GC, UV) of analysis for excipients, new chemical entities and/or drug productsInterpret data and make recommendations to management for improvement or potential concernsCompare laboratory data against specifications, prepare reports, and trend data where applicable to determine if results meet requirementsEnsure proper usage, care, and return of calibration standards including, but not limited to, reference standards, timers, thermometers, and instrumentationEnsure accuracy of testing by following method/standard instructions and adhering to internal SOPs to eliminate the potential for repeat testing, deviations, and investigationsIndependently author standard operating procedures, analytical testing procedures, final submission ready documents, and create document templates for use by junior team membersCreate report templates and/or enter data into established reports/templates or software-based systemsReview routine laboratory experiments for accuracy and provide guidance to junior team members to ensure future complianceIdentify and recommend opportunities for improved efficiencies, internal/external client service and teamwork within the analytical groupServe as a point of contact for laboratory testing support and provide updates to laboratory supervision and/or clientWith supervision, support the scheduling and planning of internal/external client project work to ensure the highest levels of efficiency and quality standards are metSupport the development of a climate of quality within the teams by driving and monitoring quality standards within the teamBecome resident expert in the use of Empower (perform supervisory sign-off for electronic reports) and other software-based systemsServe as a method troubleshooting resource to identify and document critical factors that affect method performance and assist peers in resolving method issues in a timely, cost-effective mannerIndependently perform method evaluation/development/validation and troubleshooting instruments and improvement of processesAssist laboratory management with the preparation and execution of laboratory investigations/deviations and CAPA within the electronic quality system (eQMS)Mentor and train new laboratory team members  qualifications: Analytical Acumen: Skilled in the interpretation and application of data in problem-solving, decision-making, account planning, and activity prioritization.Decision Quality: Considers all relevant factors (analysis, wisdom, experience and judgment) and uses appropriate decision-making criteria and principles.Equipment Operation: Is skilled in the use and trouble-shooting of key equipment important in the delivery of the job.Problem Solving: Build a logical approach to address problems or opportunities or manage the situation at hand by drawing on one's knowledge and experience base and calling on other references and resources as necessary.Quality: Prioritizes and delivers highest levels of quality in work and interactions with customers and team members.Self-Awareness: Self-Aware, open to coaching and self-improvement, agile and decisive in decisions. Is highly effective socially and interpersonally- adept at interpreting social and emotional cures and adapting approach and messaging accordingly.Training Others: Carefully and fully articulates methods and approaches in a way that is understood by using delivery mechanisms that meet the needs of the learner.Written Communication: Conveys ideas and facts in writing in a way that will be understood by composing in a clear, direct, concise and complete manner.  skills: Analytical Chemistry Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • greenville, north carolina
    • permanent
    • $55,000 - $60,000 per year
    job summary: This position is responsible for independently performing routine and non-routine analytical testing in support of pharmaceutical products following all applicable safety, quality, and regulation requirements.   location: Greenville, North Carolina job type: Permanent salary: $55,000 - 60,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: Key Responsibility Areas Analytical Testing: With limited supervision, perform a broad array of primary and advanced analytical testing methods (wet and dry chemistry) in compliance with all cGMP and regulatory guidelines and ensure the highest standards for efficiency, right first-time measures, and quality standardsData Interpretation and Problem-Solving: Use appropriate resources (e.g. software) to investigate and interpret data in support of recommendations for problem-solving related to methods, instruments and analytical techniquesProcess Improvement: Identify and recommend opportunities for improved efficiencies, client service and teamwork within the analytical groupQuality: Ensure the integrity of data, quality of work, products and services as a first priority; complies or exceeds all regulatory and cGMP compliance standards as well as ensure accuracy of analyses as it relates to right first-time measuresSafety: Adhere to all workplace safety laws, regulations, standards, and practices and actively advance a culture of safety within his or her team and organizationIndependently perform routine and complex testing for chromatographic and spectrophotometric methods (HPLC, GC, UV) of analysis for excipients, new chemical entities and/or drug productsCompare laboratory data against specifications and trend data where applicable to determine if results meet requirementsInterpret data and make recommendations to management for improvement or potential concernsCreate report templates and/or enter data into established reports/templates or software-based systemsUnder general supervision, author standard operating procedures, analytical testing procedures, final submission ready documents, and create document templates for use by junior team membersWith guidance, propose applicable specifications based on data obtained in support of certain programsEnsure proper usage, care, and return of calibration standards including, but not limited to, reference standards, timers, thermometers, and instrumentationEnsure accuracy of testing by following method/standard instructions and adhering to internal SOPs to eliminate the potential for repeat testing, deviations, and investigationsDirect and assist in laboratory personnel training when requiredUnder general supervision, evaluate and validate methods of analysis for chemical entities and drug product formulationsProvide assistance with method development to ensure methods are robust and able to be validatedMay serve as a technical liaison between functional groups such as Quality Assurance and metrologyConduct peer review of routine and complex laboratory experiments for accuracy and provide guidance to junior team members to ensure future complianceMaintain proficient knowledge in the use of Empower and other software-based systems; perform supervisory sign-off for electronic reports  qualifications: Attention to Detail: Thoroughness in accomplishing a task through concern for all the areas involved, no matter how small. Monitors and checks work or information and plans and organizes time and resources efficiently.Equipment Operation: Is skilled in the use and trouble-shooting of key equipment important in the delivery of the job. Listening: Active listening, hearing and learning from what others say.Operating Equipment: Understands and promotes the effective and full utilization of tools, machines, and equipment in the performance of their roles.Organization: Establish a systematic course of action for self or others to ensure accomplishment of a specific objective; set priorities, goals, and timetables to achieve maximum productivity.Quality: Prioritizes and delivers highest levels of quality in work and interactions with customers and team members.Technical Learning: Picks up on technical things quickly; can learn new skills and knowledge; is good at learning new industry, company, product, or technical knowledge; does well in technical courses and seminars.Training  skills: Analytical Chemistry Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: This position is responsible for independently performing routine and non-routine analytical testing in support of pharmaceutical products following all applicable safety, quality, and regulation requirements.   location: Greenville, North Carolina job type: Permanent salary: $55,000 - 60,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: Key Responsibility Areas Analytical Testing: With limited supervision, perform a broad array of primary and advanced analytical testing methods (wet and dry chemistry) in compliance with all cGMP and regulatory guidelines and ensure the highest standards for efficiency, right first-time measures, and quality standardsData Interpretation and Problem-Solving: Use appropriate resources (e.g. software) to investigate and interpret data in support of recommendations for problem-solving related to methods, instruments and analytical techniquesProcess Improvement: Identify and recommend opportunities for improved efficiencies, client service and teamwork within the analytical groupQuality: Ensure the integrity of data, quality of work, products and services as a first priority; complies or exceeds all regulatory and cGMP compliance standards as well as ensure accuracy of analyses as it relates to right first-time measuresSafety: Adhere to all workplace safety laws, regulations, standards, and practices and actively advance a culture of safety within his or her team and organizationIndependently perform routine and complex testing for chromatographic and spectrophotometric methods (HPLC, GC, UV) of analysis for excipients, new chemical entities and/or drug productsCompare laboratory data against specifications and trend data where applicable to determine if results meet requirementsInterpret data and make recommendations to management for improvement or potential concernsCreate report templates and/or enter data into established reports/templates or software-based systemsUnder general supervision, author standard operating procedures, analytical testing procedures, final submission ready documents, and create document templates for use by junior team membersWith guidance, propose applicable specifications based on data obtained in support of certain programsEnsure proper usage, care, and return of calibration standards including, but not limited to, reference standards, timers, thermometers, and instrumentationEnsure accuracy of testing by following method/standard instructions and adhering to internal SOPs to eliminate the potential for repeat testing, deviations, and investigationsDirect and assist in laboratory personnel training when requiredUnder general supervision, evaluate and validate methods of analysis for chemical entities and drug product formulationsProvide assistance with method development to ensure methods are robust and able to be validatedMay serve as a technical liaison between functional groups such as Quality Assurance and metrologyConduct peer review of routine and complex laboratory experiments for accuracy and provide guidance to junior team members to ensure future complianceMaintain proficient knowledge in the use of Empower and other software-based systems; perform supervisory sign-off for electronic reports  qualifications: Attention to Detail: Thoroughness in accomplishing a task through concern for all the areas involved, no matter how small. Monitors and checks work or information and plans and organizes time and resources efficiently.Equipment Operation: Is skilled in the use and trouble-shooting of key equipment important in the delivery of the job. Listening: Active listening, hearing and learning from what others say.Operating Equipment: Understands and promotes the effective and full utilization of tools, machines, and equipment in the performance of their roles.Organization: Establish a systematic course of action for self or others to ensure accomplishment of a specific objective; set priorities, goals, and timetables to achieve maximum productivity.Quality: Prioritizes and delivers highest levels of quality in work and interactions with customers and team members.Technical Learning: Picks up on technical things quickly; can learn new skills and knowledge; is good at learning new industry, company, product, or technical knowledge; does well in technical courses and seminars.Training  skills: Analytical Chemistry Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • greenville, north carolina
    • permanent
    • $90,000 - $100,000 per year
    job summary: This position leads and supports formulation and process development activities while serving as a primary point of contact with the client regarding pharmaceutical development and clinical manufacturing project related activities. This role is responsible for supporting these activities in the areas of supervision, process development, clinical trial batch manufacturing, packing and documentation.   location: Greenville, North Carolina job type: Permanent salary: $90,000 - 100,000 per year work hours: 8 to 4 education: Masters   responsibilities: People Development: Lead in the development of a culture, and supporting systems, to drive open communication, participation, and idea-sharing in order to build an engaged team, advances and models Mayne Pharma values and leadership commitmentsPharmaceutical Development: Manage formulation development activities to develop stable and robust formulations, using Quality by Design PrinciplesProcess Optimization: Identify and recommend opportunities for improved efficiencies and teamwork across the Pharmaceutical Development groupScientific Excellence: Design and execute experiments in support of potential new technological offerings as well as participate or support research articles and publications Specific Responsibilities Responsibilities include, but are not limited to: Independently design, coordinate, and execute all product development activities including material characterization, excipient selection, prototype manufacture, equipment selection, generation of batch records, scale-up, QbD, and registration batch activitiesWork closely with analytical scientists, project management, quality and commercial operations to ensure that formulation and process development are appropriate and timelyWrite all the required documentations such as batch records, product development reports, risk assessments, and campaign summariesCommunicate effectively with internal staff, clients, and external vendorsResponsible for GMP compliance in formulation and process developmentSupport and contribute to qualification of facility and equipmentCoordinate with logistics and scheduling groups to help ensure that an adequate inventory of raw materials is maintained at all timesMaintain competence and training documentation for relevant equipment and processes  qualifications: Agile & Flexible: Leads and embraces change. Fosters innovation by challenging the status quo and initiating new ways of working.Celebrator: Embraces a culture of action. Sets challenges and achieves results. Celebrates and rewards achievements of team members.Communicator/Collaborator: Builds shared meaning through open and respectful communication. Engages stakeholders in pertinent conversations, and creates an atmosphere that is inclusive and consultative.Leads Self: Maximizes personal potential by focusing on ongoing professional growth. Takes initiative, honors promises, and acts with courage.People Developer: Empowers, inspires, and challenges team members. Fosters high performance and development.Purpose Driven: Drives vision and purpose by creating and contributing to strategic direction. Aligns priorities to organizational goals.Solutions Focused: Solves problems once and simplifies issues. Makes problems visible and acts decisively.Team Builder: Builds and optimizes a high performing team. Creates a sense of belonging and connectivity among team members.Conflict Resolution: Bring substantial conflicts and disagreements into the open and attempt to manage them collaboratively, building consensus, keeping the best interests of the organization in mind, not only one's own interestLeadership: Motivate others, share knowledge, drive high performing teams, show respect towards others and provide constructive feedbackPh.D. in Pharmaceutical Science or related field or Pharm.D. with at least 4 years of industrial product development experienceMaster's degree in pharmaceutical science, chemistry, or related science with at least 5 years of industrial pharmaceutical experienceBachelor's degree in pharmaceutical science, chemistry, engineering or related science with at least 6 years of industrial pharmaceutical experience  skills: GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: This position leads and supports formulation and process development activities while serving as a primary point of contact with the client regarding pharmaceutical development and clinical manufacturing project related activities. This role is responsible for supporting these activities in the areas of supervision, process development, clinical trial batch manufacturing, packing and documentation.   location: Greenville, North Carolina job type: Permanent salary: $90,000 - 100,000 per year work hours: 8 to 4 education: Masters   responsibilities: People Development: Lead in the development of a culture, and supporting systems, to drive open communication, participation, and idea-sharing in order to build an engaged team, advances and models Mayne Pharma values and leadership commitmentsPharmaceutical Development: Manage formulation development activities to develop stable and robust formulations, using Quality by Design PrinciplesProcess Optimization: Identify and recommend opportunities for improved efficiencies and teamwork across the Pharmaceutical Development groupScientific Excellence: Design and execute experiments in support of potential new technological offerings as well as participate or support research articles and publications Specific Responsibilities Responsibilities include, but are not limited to: Independently design, coordinate, and execute all product development activities including material characterization, excipient selection, prototype manufacture, equipment selection, generation of batch records, scale-up, QbD, and registration batch activitiesWork closely with analytical scientists, project management, quality and commercial operations to ensure that formulation and process development are appropriate and timelyWrite all the required documentations such as batch records, product development reports, risk assessments, and campaign summariesCommunicate effectively with internal staff, clients, and external vendorsResponsible for GMP compliance in formulation and process developmentSupport and contribute to qualification of facility and equipmentCoordinate with logistics and scheduling groups to help ensure that an adequate inventory of raw materials is maintained at all timesMaintain competence and training documentation for relevant equipment and processes  qualifications: Agile & Flexible: Leads and embraces change. Fosters innovation by challenging the status quo and initiating new ways of working.Celebrator: Embraces a culture of action. Sets challenges and achieves results. Celebrates and rewards achievements of team members.Communicator/Collaborator: Builds shared meaning through open and respectful communication. Engages stakeholders in pertinent conversations, and creates an atmosphere that is inclusive and consultative.Leads Self: Maximizes personal potential by focusing on ongoing professional growth. Takes initiative, honors promises, and acts with courage.People Developer: Empowers, inspires, and challenges team members. Fosters high performance and development.Purpose Driven: Drives vision and purpose by creating and contributing to strategic direction. Aligns priorities to organizational goals.Solutions Focused: Solves problems once and simplifies issues. Makes problems visible and acts decisively.Team Builder: Builds and optimizes a high performing team. Creates a sense of belonging and connectivity among team members.Conflict Resolution: Bring substantial conflicts and disagreements into the open and attempt to manage them collaboratively, building consensus, keeping the best interests of the organization in mind, not only one's own interestLeadership: Motivate others, share knowledge, drive high performing teams, show respect towards others and provide constructive feedbackPh.D. in Pharmaceutical Science or related field or Pharm.D. with at least 4 years of industrial product development experienceMaster's degree in pharmaceutical science, chemistry, or related science with at least 5 years of industrial pharmaceutical experienceBachelor's degree in pharmaceutical science, chemistry, engineering or related science with at least 6 years of industrial pharmaceutical experience  skills: GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

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