Supervisor, Visual Inspection Program 503B
On-site · Allentown, Pennsylvania, United States
Job Summary
Supervisor responsible for managing the visual inspection program for sterile products in a 503B environment. Develop and maintain validated inspection methods, acceptance criteria and defect classification; supervise, train and qualify visual inspectors; prepare training materials for defect recognition and inspection technique; schedule personnel to meet production and release timelines; lead or support investigations related to inspection failures and CAPA development; monitor inspection performance metrics and maintain audit-ready documentation; ensure compliance with 21 CFR Parts 210/211, 503B guidance, USP <790>/<1790>, and facility SOPs; contribute to internal audits and external inspections; perform related duties as assigned.
Required Qualifications
- Bachelor’s degree required or equivalent combination of education and experience.
- Experience in sterile pharmaceutical manufacturing, ideally within a 503B or 21 CFR 210/211 regulated environment.
- Strong understanding of visual inspection requirements for sterile parenteral products.
- Prior supervisory or team-lead experience in a cGMP setting.
- Ability to work non-standard schedule as needed.
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