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 standards
- Client 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 responsiveness
- Data Integrity: Ensure integrity of data through accurate transactions, documentation, and tracking of all cGMP activities
- Data 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 group
- Quality: 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 measures
- Safety: 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 products
- Interpret data and make recommendations to management for improvement or potential concerns
- Compare laboratory data against specifications, prepare reports, and trend data where applicable to determine if results meet requirements
- Ensure proper usage, care, and return of calibration standards including, but not limited to, reference standards, timers, thermometers, and instrumentation
- Ensure accuracy of testing by following method/standard instructions and adhering to internal SOPs to eliminate the potential for repeat testing, deviations, and investigations
- Independently author standard operating procedures, analytical testing procedures, final submission ready documents, and create document templates for use by junior team members
- Create report templates and/or enter data into established reports/templates or software-based systems
- Review routine laboratory experiments for accuracy and provide guidance to junior team members to ensure future compliance
- Identify and recommend opportunities for improved efficiencies, internal/external client service and teamwork within the analytical group
- Serve as a point of contact for laboratory testing support and provide updates to laboratory supervision and/or client
- With supervision, support the scheduling and planning of internal/external client project work to ensure the highest levels of efficiency and quality standards are met
- Support the development of a climate of quality within the teams by driving and monitoring quality standards within the team
- Become resident expert in the use of Empower (perform supervisory sign-off for electronic reports) and other software-based systems
- Serve 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 manner
- Independently perform method evaluation/development/validation and troubleshooting instruments and improvement of processes
- Assist 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.
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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.
