GMP QA Inspector I – Packaging & Documentation

Sharp Packaging Solutions, part of UDG Healthcare plc; Conshohocken (Montgomery County); On-site; USD 45,000 - 60,000; Full time

Job summary

Sharp Packaging Solutions is seeking a QA Inspector Level I to help enforce GMP compliance on the production floor, inspect components and finished goods, and verify batch records. You will review documentation, verify equipment and room identifications, and ensure results align with CoA/CoC and related forms.

The role emphasizes accuracy, traceability, and accountability across shift transitions, with attention to documentation quality and adherence to SOPs in a packaging environment.

Qualifications

• Associate or bachelor’s degree preferred or high school degree with 1–2 years related experience.
• Experience in inspection of pharmaceutical or related industry is desirable.
• General knowledge of FDA regulations related to cGMPs is desired.
• Good documentation and communication skills are required.
• Good organizational and planning skills are required.

Responsibilities

• Ensure GMP compliance on the production floor, including gowning, hygiene, material handling, and documentation.
• Verify documentation, room identification, equipment and incoming components to a packaging room.
• Ensure batch records are accurate and complete; read process steps to ensure packaging compliance.
• Review batch records for requests, deviations, change controls; ensure cleaning logs are complete.
• Verify components attributes (lot number, expiration, description, item number, quantity) against supporting documentation.
• Ensure batch records are executed by all associates according to process steps.
• Review batch records for accuracy, legibility, traceability, and accountability.
• Pull and identify retain samples per batch record requirements.
• Verify challenges performed according to SOP and batch record requirements.

Skills

GMP compliance

Good documentation practices

Communication skills

Organizational skills

Attention to detail

Education

Associate or bachelor's degree preferred

High School Degree with 1–2 years related experience

Job description

Sharp Packaging Solutions is seeking a QA Inspector Level I to help enforce GMP compliance on the production floor, inspect components and finished goods, and verify batch records. You will review documentation, verify equipment and room identifications, and ensure results align with CoA/CoC and related forms.

The role emphasizes accuracy, traceability, and accountability across shift transitions, with attention to documentation quality and adherence to SOPs in a packaging environment.