Position based in Allentown, PA, within the Production area, onsite working model, 5X8 shift schedule (Wednesday, Tuesday, Thursday, Friday, Monday), no relocation assistance.
Responsibilities include managing the visual inspection program for sterile products, ensuring compliance with regulatory standards (21 CFR Parts 210/211, 503B, USP <790>/<1790>), supervising and training inspectors, developing training materials, scheduling personnel, supporting investigations, and maintaining audit-ready documentation.
Qualifications require a Bachelor's degree or equivalent, experience in sterile pharmaceutical manufacturing, knowledge of visual inspection for sterile products, and supervisory experience in a cGMP environment. Must be able to work flexible hours and occasionally lift up to 20 pounds.
Skills include knowledge of GMP regulations, inspection techniques, team leadership, and problem-solving. The role emphasizes safety, quality, and compliance in a regulated manufacturing setting.