Inspection Team Lead, 2nd Shift
About The Position
The Inspection Team Lead is a key role within INCOG BioPharma Operations, requiring subject matter expert (SME) capabilities in the inspection of sterile drug products. The ideal candidate must have experience in the inspection and packaging of pharmaceutical drug products. The primary responsibility is to perform continuous monitoring of the inspection process, provide in-process daily review of executed batch records and form entries, and inspect finished products to identify and remove defects according to standard procedures. This role is responsible for meeting production standards, maintaining product quality, minimizing equipment downtime, ensuring compliance with quality systems, policies, procedures, and cGMP practices, and collaborating effectively with internal partners, clients, and vendors.
Requirements
- High School diploma required
- Minimum 2 years of GMP pharmaceutical experience in drug product inspection and/or packaging
- Must pass health and visual check and eye inspections annually for visual acuity and color blindness
- Aware of industry guidances and requirements applicable to visual inspection, including USP <790> and <1790> and FDA Draft Guidance: Inspection of Injectable Products for Visible Particulates (2021).
Nice To Haves
- Previous manufacturing leadership experience
- Good math and documentation skills
- Ability to perform repetitive tasks
- Ability to learn and adapt to innovative ideas
- Good observation skills
- Initiative-taking and Collaborative
- Effective organization skills and diligent
- Ability to work with minimal supervision
Responsibilities
- 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 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 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
- Collaborate and communicate with cross functional teams
- Work flexible hours to ensure production facility coverage
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
