Working as a Quality Systems Specialist under the Northern California Quality Assurance Operations team, you will support manufacturing activities including investigations of product non- conformance and deviations, blocking of non- conforming material, batch record and CoA review and release. Leveraging your knowledge of Quality principles, you’ll guide the manufacturing partners in correct path for cause investigation and issue resolution. You’ll provide feedback on best practice for documentation and Quality record updates to reinforce client's Quality Management System.
Work location - Richmond, CA - 100% Onsite - 6 months (may extend)
How You'll Make An Impact:
- Support client's top business priority: BioPharma Demand
- Support batch release for LSG mfg sites
- Support Veeva integration for NorCal (Change Control, Nonconformance Management)
- Verification of Change Control activities
- Rapid containment of product quality issues (either from manufacturing issue or a customer complaint issue)
- Audit preparedness, to reduce audit findings
What You Bring:
- Associate degree or equivalent in Biology, Chemistry, or related field. 2+ years experience in a regulated manufacturing industry or equivalent combination of education and experience.
- Understanding of GMP/ISO regulations (ISO 13485, MDSAP, FDA 820/210/211).
- Working knowledge of device/drug/biotech manufacturing processes.
- Detail-oriented, excellent organization and project management skills and ability to multitask.
- Decision making, time management, organization, communication, leadership, and computer skills.
- Proficient in Microsoft Office, Visio and Excel SalesForce and SAP experience is a plus
