Shop Floor QA Specialist II (Orange County, CA)
SNAPSHOT!
Are you looking for an exciting career opportunity with a technology-based special pharmaceutical company focused on the development and commercialization of therapeutic injectable drugs? THEN READ ON! Our client has a full array of expertise, including advanced scientific research in the area of drug delivery systems, process development, patent analysis, and regulatory compliance!
Immediate need for a Shop Floor QA Specialist II in Orange County, CA who possess:
- Bachelor’s degree in chemistry or biology; or equivalent combination of education and experience.
- 3 - 5 years of related manufacturing and quality assurance in the pharmaceutical industry
- Broad knowledge of scientific theories, instrumentation, and techniques
- Thorough knowledge of GMPs, GLPs and pharmaceutical products
- Working knowledge of all phases of Pharmaceutical manufacturing and laboratory operations
- 1 year writing, editing, or reviewing documents such as SOPs, work instructions, batch records, guidelines, etc. Technical Writing experience a plus
Key responsibilities include:
- QA oversight during manufacturing activities such as filling, compounding, component preparation, capping, inspection, labeling, and packaging operations
- Review executed batch record
- Make quality decisions on the floor during commercial manufacturing
- Review batch record documentation and logbooks concurrent with manufacturing operations
- Verify line clearance activities for manufacturing and packaging area
- Monitor the inspection and packaging lines and perform AQL inspections
- 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
- Train new employees on QA Shop Floor Associate’s functions
- Support QADC team to issue controlled documents as needed
- Facilitate manufacturing deviations and investigations
- Other quality assurance duties as assigned and required to meet relevant 21 CFR Part 210 and 211
For immediate considerations please email your resume to admin@snapstaffing.com