GMP QA Inspector I: Documentation & Compliance

Sharp Services; Conshohocken (Montgomery County); On-site; USD 50,000 - 65,000; Full time

Job summary

Sharp Services is seeking a QA Inspector Level I to enforce GMP compliance on the production floor, review batch records, and verify documentation and components for packaging operations. The role ensures accuracy, traceability, and adherence to SOPs, with a focus on quality control and regulatory alignment.

The candidate will monitor equipment calibration, room identification, and batch record integrity, supporting overall product quality and regulatory compliance.

Qualifications

• Associate or bachelor’s degree preferred; high school with 1–2 years related experience acceptable.
• General knowledge of FDA/cGMPs and quality control/assurance desired.
• Good documentation and communication skills required; strong organization and planning abilities.

Responsibilities

• Ensure GMP compliance on production floor, including gowning, hygiene, material handling and documentation.
• Verify and document room identification, equipment, and incoming components for packaging.
• Review batch records for accuracy (lot numbers, expiration dates, item numbers) and compliance with SOPs.
• Ensure calibration status and asset numbers are correctly recorded in batch records.
• Verify component attributes (lot number, expiration, description, item number, quantity) against supporting docs.
• Ensure batch records are executed by all associates and are legible, traceable, and accountable at end of shift or lot.

Skills

Documentation

Communication

Organization

Planning

Education

Associate or Bachelor's degree

High School Diploma with related experience

Job description

Sharp Services is seeking a QA Inspector Level I to enforce GMP compliance on the production floor, review batch records, and verify documentation and components for packaging operations. The role ensures accuracy, traceability, and adherence to SOPs, with a focus on quality control and regulatory alignment.

The candidate will monitor equipment calibration, room identification, and batch record integrity, supporting overall product quality and regulatory compliance.