Job Title: Shop Floor QA Role
Location: Irvine, CA
Duration: 12+ months ContractJob Description:
The Quality Assurance Shop Floor provides QA oversight during manufacturing activities such as filling, compounding, component preparation, capping, inspection, labeling, and packaging operations. QA Shop Floor will also contribute to the training of new employees on QA Shop Floor Associate’s functions. Primary Responsibilities
- Provide shop floor QA oversight for Sterile Manufacturing activities.
- Ability to make quality decisions on the floor during commercial manufacturing.
- Communicate quality-related observations to management and production personnel and initiate deviations as needed.
- Review batch record documentation and logbooks concurrent with manufacturing operations.
- Verify line clearance activities for manufacturing and packaging area.
- Evaluate manufacturing issues and review Special Attention Notices.
- Assist monitoring the inspection and packaging lines by performing AQL inspections and line challenge verification as needed.
- Monitor the production schedule and ensure adequate line coverage support from QA.
- Perform routine quality inspection of filling, compounding, component preparation, capping, inspection, labeling, packaging, and warehouse.
- Support validation and manufacturing studies including special sampling and testing.
- Participate in developing and revision of batch record and SOPs.
- Providing immediate assistance and support for the sterile manufacturing activities.
- Perform retain inspection as a certified inspector.
Qualifications• 5 years of aseptic/ sterile experience.
- 7 years of GMP or cGMP manufacturing experience.
- Experience with measuring tools and laboratory equipment.
- Experience performing audits on the manufacturing floor
Job Type: Full-time
Pay: $17.00 - $80.00 per hour
Schedule:
Ability to commute/relocate:
- Irvine, CA: Reliably commute or planning to relocate before starting work (Required)
Experience:
- Quality Assurance Managers: 5 years (Required)
Work Location: In person
