Senior QA Specialist - cGMP Compliance & Release

Fagron Nederland BV; Canton, Northern (MA, KY); Hybrid; USD 110,000 - 150,000; Full time

Job summary

Fagron US is seeking a Quality Assurance Senior Specialist to lead QA activities across Level 1–3 in a cGMP pharm manufacturing environment. You will ensure proper controls, documentation, and product disposition for compounded products, while supporting audits and process improvements.

The role requires extensive QA experience, familiarity with quality systems, and strong documentation practices. Join a global pharma leader and contribute to compliant manufacturing operations.

Qualifications

• College degree and 8–10 years cGMP experience in pharma manufacturing or equivalent.
• Experience with quality systems, aseptic technique, and cGMP document review.
• Proficient with MS Office programs (Word/Excel).
• Ability to process information from multiple sources and communicate clearly.
• Ability to handle high workload and adapt to changing environment.

Responsibilities

• Execute Level 1 QA tasks: manufacturing/packaging clearances, label review, reconciliation.
• Execute Level 2 QA tasks: batch record issuance/review/approval, material review.
• Execute Level 3 QA tasks: disposition/release of materials and finished product.
• Support QA projects of low to moderate complexity as assigned.
• Assist with internal, corporate, 3rd party and federal/state inspections and audits.
• Ensure cGMP documentation meets ALCOA standards and maintain training SOPs.

Education

Bachelor's degree

Tools

MasterControl

Excel

Word

Job description

Fagron US is seeking a Quality Assurance Senior Specialist to lead QA activities across Level 1–3 in a cGMP pharm manufacturing environment. You will ensure proper controls, documentation, and product disposition for compounded products, while supporting audits and process improvements.

The role requires extensive QA experience, familiarity with quality systems, and strong documentation practices. Join a global pharma leader and contribute to compliant manufacturing operations.