This role will serve as the liaison between Quality Control (QC) and clients. The QC Client Representative will work with Program Management and clients to establish testing in the Quality Control lab, external contract testing laboratories and stability programs. This role will also work with the Analytical Development group on qualification and transfer of methods into QC.
Key Responsibilities include, but are not limited to:
- Attend client meetings to establish testing and stability protocols
- Ensure completion of project team assigned QC related activities.
- Coordinate internal testing with Quality Control group
- Coordinate product and raw material testing with external testing laboratories
- Coordinate with the stability group and clients to establish stability studies.
- Review and approve client sampling plans.
- Review and approve batch records. Ensure sample testing schedule is accurate.
- Develop and maintain QC client activities tracker.
- Communicate manufacturing and testing schedules to the Quality Control group.
- Effectively communicates with clients on QC related items/results.
- Flexibility in following unique campaign requirements that may include off-hour and weekend work
- Other duties as assigned
Education & Experience:
- Bachelor degree in Life Science and/or analytical discipline
- Minimum of 8 years experience in analytical and/or microbiological testing and/or management of testing of biologicals in a GMP environment required
- Project Management and Contract Manufacturing experience necessary
- Comprehensive and practical working knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP and EP, and other applicable regulatory guidances (US and EU).
- Strong focus on responsiveness, ability to multi-task, attention to detail, effective problem solving skills, consistent follow-up and ability to make timely and sound decisions (Quality and Business). Must be able to prioritize.
- Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike (transversally collaborative) across functional groups and levels and with external clients.
- Ability to analyze information and solve problems relating to Quality Control.
- Experience with Microsoft Excel and Microsoft Word
- Strong attention to detail
- Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality task.