SUMMARY OF FUNCTIONS:
Oversee the laboratory and staff in the performance of container qualification testing.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Perform all work duties in an exceptional manner as assigned under the job description.
- As required, independently perform container qualification testing on packaging components such as bottles, vials, and stoppers according to USP, EP, JP, etc.
- Work in conjunction with the QAU in Out of Specification (OOS) investigations, using knowledge and experience to assist in the determination of the cause of failure.
- Assist clients in discussion of appropriate testing required for their particular package or component.
- Provide leadership and direction to personnel assigned as supervisee(s), ensuring timely completion of quality work.
- Review and approve analytical work completed by assigned supervisee(s).
- Assist with management of laboratory equipment inclusive of instrument calibrations, performance verification, IQ, OQ, PQ
- Coordinate laboratory training sessions for assigned supervisee(s) as needed.
- Assist with various laboratory administrations such as sample receipt, quote generation, supply order and receipt.
Reports to: Associate Director(s) of Container Qualification & CCIT
EXPERIENCE OR SKILL REQUIREMENTS:
- College degree in science-related field, 3 or more years of experience in a laboratory environment preferred.
- Knowledge and experience with common container testing methods required, including USP <660>, <661>, <671>, <381>. Strong chemistry background preferred.
- Operational knowledge of the following laboratory instruments strongly preferred: FTIR, UV-VIS, DSC, HPLC, ICPExperience with USP Extractables and Leachables testing preferred.
- Solid proficiency in Microsoft Office, inclusive of Outlook, Word, and Excel required.
Associate Director, CCIT