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.

Sample Testing:

  • 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.

Laboratory Supervision:

  • 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.

ORGANIZATIONAL RELATIONSHIPS:
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.

CONTACT

Brandon Zurawlow
Associate Director, CCIT
wlcontainers@amriglobal.comJ

Justine Young
Associate Director
wlcontainers@amriglobal.com