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Inspection & Packaging Team Lead, 3rd Shift
INCOG BioPharmaUnited Statesfull_timeVerifiedPosted 10 Feb 2025
About the role
Individual with subject matter expert (SME) capabilities in the inspection and/or packaging of sterile drug products. The Inspection/Packaging Lead is a key role within INCOG BioPharma Operations. The ideal candidate must have experience in the inspection and packaging of pharmaceutical drug products. The primary responsibility of the Inspection/Packaging Team Lead is to perform continuous monitoring of the inspection process and provide in-process daily review of executed batch record and form entries. In addition they will perform inspection to identify and remove critical, major, and minor defects from finished product according to standard procedures. They will be responsible for meeting/exceeding production standards, maintaining product quality, and minimizing/preventing equipment downtime. The ideal candidate will ensure compliance with quality systems, policies, procedures, and cGMP practices and collaborate effectively with internal partners, clients, and vendors. This is a 3rd Shift position. Essential Job Functions:
- Assist Inspection Supervisor, supporting a team of 6 to 10 associates daily, to inspect and package syringes and vials.
- Follow production and manufacturing procedures.
- Inspect filled product container for cosmetic, particle and integrity defects.
- Perform reconciliation of finished inspected/packaged product and defects.
- Assist in writing and implementing area’s process documents.
- Operate equipment in compliance with SOPs.
- Assure compliance with cGMP requirements (current good manufacturing practices).
- Complete and review associated production records, logbooks and forms.
- Assist in performing and documenting Knapp and probability of detection studies.
- Train new inspectors in accordance with inspector certification procedures.
- Mentor new inspection / packaging associates.
- Train new employees to perform manufacturing inventory transactions in the ERP system.
- Assist other manufacturing functions (Formulation, Fill, Materials) as required.
- Perform duties gowned in Grade C, D, and controlled non-classified cleanrooms.
- Perform cleaning and sanitization activities as needed.
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