cGMP Batch Record Compliance Specialist

Sharp Clinical Services; Macungie (Lehigh County); On-site; USD 45,000 - 65,000; Full time

Job summary

Sharp Clinical Services seeks a detail‑oriented Documentation Reviewer to ensure packaging records comply with cGMP requirements and customer specifications. You will log issues, support QA in audits, and coordinate the release of work in process and finished products.

Primary responsibilities include reviewing primary, secondary, and clinical packaging documentation, following up on customer inquiries, and maintaining documentation in current status locations.

Job description

Sharp Clinical Services seeks a detail‑oriented Documentation Reviewer to ensure packaging records comply with cGMP requirements and customer specifications. You will log issues, support QA in audits, and coordinate the release of work in process and finished products.

Primary responsibilities include reviewing primary, secondary, and clinical packaging documentation, following up on customer inquiries, and maintaining documentation in current status locations.