QA Inspector I: GMP Compliance & Batch Records

Sharp Clinical Services; Conshohocken (Montgomery County); Sur place; USD 42 000 - 54 000; Plein temps

Résumé du poste

Sharp Clinical Services is seeking a QA Inspector Level I to ensure GMP compliance across the production floor, verify documentation and batch records, and oversee component verification for packaging processes. The role emphasizes maintaining data integrity, hygiene, and accurate record-keeping in a regulated environment.

The ideal candidate will have an associate or bachelor’s degree (or a high school diploma with 1–2 years’ related experience) and solid knowledge of FDA cGMPs, quality

Qualifications

• Good documentation and communication skills required.
• Strong organizational and planning skills required.
• General knowledge of FDA regulations related to cGMPs and quality control/assurance is preferred.

Responsabilités

• Enforce GMP compliance on production floor (gowning, hygiene, handling/storage, documentation).
• Verify batch records, room identification, equipment, and incoming components to packaging.
• Ensure batch records are accurate, legible, and traceable; review deviations, change controls and memos.
• Ensure calibration and labeling of equipment; verify component attributes against documentation.
• Pull and identify retain samples; ensure batch records are executed per SOPs and process steps.

Connaissances

Documentation

Communication

Organization

Planning

Quality assurance

FDA cGMPs

Formation

Associate or Bachelor's degree preferred

High School Diploma with 1–2 years related experience

Description du poste

Sharp Clinical Services is seeking a QA Inspector Level I to ensure GMP compliance across the production floor, verify documentation and batch records, and oversee component verification for packaging processes. The role emphasizes maintaining data integrity, hygiene, and accurate record-keeping in a regulated environment.

The ideal candidate will have an associate or bachelor’s degree (or a high school diploma with 1–2 years’ related experience) and solid knowledge of FDA cGMPs, quality