Role overview
Embedded QA professional providing routine quality presence on the manufacturing and packaging floor. Strengthens real-time oversight, cGMP behaviors and batch documentation quality during the remediation program.
Key responsibilities
- Provide daily QA presence on manufacturing and packaging lines
- Verify clean equipment and room status; oversee line clearance and batch start-up
- Support batch record review and correct documentation issues at source
- Coach operators on cGMP behaviors and good documentation practice (ALCOA+)
- Identify, escalate and trend floor-level events; support human-error reduction actions
- Contribute to cleaning and line-clearance procedure updates and floor-level training
Mandatory requirements
- 5+ years of GMP manufacturing QA with direct shop-floor support
- Experience with batch record review, line clearance and in-process QA checks
- Strong working knowledge of good documentation practice and data integrity on the floor
- Able to work on-site full time, including flexible shift coverage when approved
Plus the common requirements listed on page 1.
Preferred qualifications
- Solid oral dosage (tableting, encapsulation, coating) and/or packaging experience
- Experience in sites under regulatory remediation
- Experience with electronic batch records and MES
