internal auditor salaries in raleigh, north carolina

job summary: We are seeking a highly motivated and experienced Associate in Quality Control (QC) Chemistry to support the startup and operational readiness of our QC laboratory. Working with minimal supervision, this individual will lead and contribute to critical activities including system qualifications, method transfers, and laboratory operations in a GMP-regulated environment.   location: Holly Springs, North Carolina job type: Contract salary: $29.00 - 33.56 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Collaborate cross-functionally with site teams to implement work order and preventative maintenance systems for laboratory equipment.Review and contribute to validation documentation to support onboarding of equipment and computerized systems.Draft, revise, and review technical and quality documentation such as SOPs, test methods, technical assessments, validation reports, trend reports, and safety evaluations.Assist in the procurement of laboratory consumables and critical reagents required for startup activities.Coordinate and execute training and method transfer activities for instruments including H/UPLC, TOC, Conductivity, Osmolality and other chemistry-based platforms.Actively participate in audits, quality initiatives, and cross-functional projects with site or global impact.Provide routine operational support during weekends and public holidays as required.  qualifications: Bachelor's degree or higher in Chemistry, Compendial testing or a related scientific discipline.Minimum of 4 years of relevant laboratory experience in a GMP pharmaceutical or biopharmaceutical manufacturing environment, with a strong background in analytical testing.Proficient in analytical laboratory techniques and instrumentation.Familiarity with laboratory systems such as LIMS and LMES/CIMS.Demonstrated understanding of industry regulations, data integrity, and compliance standards.Strong technical writing, documentation, and communication skills.Experience with method validation, verification, and transfer.Excellent interpersonal skills with the ability to collaborate across teams and adapt to varying communication styles.  skills: Chemistry, Laboratory Information Management Systems (LIMS), Ultra Performance Liquid Chromatography (UPLC), High Pressure Liquid Chromatography (HPLC), Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Quality Control (QC) 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.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days.

job summary: Operational Readiness Project Manager On-Site Position | RTP, NC 6 Month Initial Contract Max Rate: $108PH Are you a seasoned project manager with a passion for operational excellence in pharmaceutical manufacturing? We're looking for someone to lead readiness efforts for a major modernization initiative at a cutting-edge drug substance facility. Why This Role Stands Out: On-site at a high-impact pharmaceutical facility in RTP, NCStandard Mon-Fri schedule with occasional overtimeDaily collaboration with project teams, contractors, and site operationsFast-paced, open office environment with real-time decision-making   location: Durham, North Carolina job type: Contract salary: $100 - 108 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Lead Cross-Functional Teams: Drive project execution across QA, Automation, Manufacturing, and Manufacturing Technical Operations.Operational Readiness: Map "current vs. future state" for manufacturing changes and execute actionable deliverables.Autonomous Execution: Manage assigned workstreams independently while providing clear, high-level status roll-ups to leadership.Strategic Communication: Lead discussions to define action plans, mitigate risks, and ensure on-time delivery.  qualifications: Industry Expertise: Proven PM experience in Large-Scale Drug Substance manufacturing.Hands-on experience: with MES/Electronic Batch Record design or implementation.Direct operations: QA with Drug Substance and/or Drug Product Manufacturing. #LI-AH1   skills: Project Management, MS-Project, Good Manufacturing Practices (GMP), Batch Record 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.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days.

job summary: Summary: Implement worldwide regulatory product registration strategies, prepare complex registration dossiers, establish and maintain tracking of product registrations to determine what products can be shipped to intended markets in accordance with business plan with a specific focus on labeling, labeling requirements, and implementation. Coordinate and submit all regulatory documentation for establishment of new / changed local market authorization holders and distributors. Minimum Requirements: Sr. Specialist II Bachelor's degree in relevant discipline, or equivalent work experience industry regulatory experience.Minimum 5 years of related technical and/or regulatory experience in pharmaceutical industry or an equivalent combination of education and experience.Experience with biological products related to but not limited to facilities, validation, environmental monitoring, cGMP manufacturing, QA/QC for biological products, compliance and/or regulatory is required.Excellent written and verbal communication skills.Knowledge of applicable laws and regulations Manager Bachelor's degree in relevant discipline, or equivalent work experience industry regulatory experience.6 to 7 years related technical and/or regulatory experience in pharmaceutical industry, or an equivalent combination of education and experience.Extensive knowledge of applicable worldwide regulatory product registrations laws and regulations.Excellent verbal and written communication skills   location: Clayton, North Carolina job type: Permanent salary: $100,000 - 120,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: Act as Regulatory Affairs authority for key product registrations with a main focus in labeling and labeling related activities.Analyze and determine worldwide product registration requirements for specific assigned products and regions. Implement worldwide regulatory registration strategy, communicate and negotiate with local market authorization holders / distributors / regulatory authorities the information required and prepare regulatory submissions to be used worldwide for all marketed products.Prepare complex registration dossiers, local application forms; negotiate documentation required for worldwide markets which may include product custom clearance documentation and coordinate with International Customer Service, Quality and Commercial preparation of required documentation in accordance with local requirements.Prepare responses to regulatory agency inquiries.Coordinate with local authorities and Quality standards and controls required for product registration testing.Represent the regulatory function in communication with outside companies, customers and regulatory authorities. Responsibilities may include preparation and presentation (if required) to regulatory authorities. (e.g. labeling specific projects).Represent the regulatory function on project teams as related to worldwide product registrations. Provide information that is presented to, for example, the Peer Review Committee, the Site Leadership Team and the Quality Management Review to enable informed decisions.Collaborate with all disciplines to assure appropriate testing and documentation are generated for regulatory submissions and routine import documentation. Prepare personnel from affiliates or third parties for meetings with regulatory authorities.Coordinate and interact with domestic and international regulatory counterparts to obtain input regarding regulatory considerations and decisions to formulate regulatory strategy for changes to products/facilities/equipment with an impact on product labeling.Request and obtain all required FDA export documentation required for registration and routine product shipments.Evaluate impact of new labeling regulatory requirements as well as evaluate changes to existing product labeling on assigned projects and products and inform other departments as necessary.Maintain worldwide product registration status and distribute routine updates to commercial, sales and Quality to determine where registered products can be marketed.Mentor and support the professional development of staff.Perform other duties as required.  qualifications: Minimum Requirements: Sr. Specialist II Bachelor's degree in relevant discipline, or equivalent work experience industry regulatory experience.Minimum 5 years of related technical and/or regulatory experience in pharmaceutical industry or an equivalent combination of education and experience.Experience with biological products related to but not limited to facilities, validation, environmental monitoring, cGMP manufacturing, QA/QC for biological products, compliance and/or regulatory is required.Excellent written and verbal communication skills.Knowledge of applicable laws and regulations Manager Bachelor's degree in relevant discipline, or equivalent work experience industry regulatory experience.6 to 7 years related technical and/or regulatory experience in pharmaceutical industry, or an equivalent combination of education and experience.Extensive knowledge of applicable worldwide regulatory product registrations laws and regulations.Excellent verbal and written communication skills Preferred Background: Advanced degree with clinical experienceExperience working on global labeling initiatives and submissionsFamiliarity with electronic labeling systems and regulatory publishing toolsDemonstrated leadership in cross-functional team settings Knowledge, Skills, and Abilities: Ability to prioritize and initiate contacts essential to labeling submission preparation.Ability to work independently and initiate contacts essential to create labeling components for submission preparation while ensure technical information is accurate.Knowledge of product and labeling history to maintain consistency within a product line and within the product portfolio labeling.Ability to clearly communicate verbally and in writing with internal and external contacts that may include industry representatives, affiliates, third parties and regulatory authorities in various countries.Ability to work with management of other Company departments to achieve common business goals as well as regulatory objectives.Ability to review a document, including labeling, in detail to ensure accuracy based on regulatory requirements, and to ensure the use of the appropriate forms, format, content, and authorized signatures.Ability to effectively use Microsoft Office (particularly Word and Excel) to create, edit, and format documentsAbility to work with other computer systems for filing supplements and reports.Ability to interpret and effectively communicate regulatory requirements internally as well as to distributors/affiliates with a specific focus in labeling.Ability to successfully interact with external contacts which may include worldwide distributors / Company affiliates / regulatory agencies through professional, articulate, and courteous conversations and clear, concise written communications.Ability to meet statutory deadlines to ensure compliance, as well as business timelines to accomplish company objectives. #LI-JW1   skills: Biologics, Labeling Compliance 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.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days.