Quality Control Analyst III/ Document Control
A biomedical manufacturing company located in Sunnyvale, CA is seeking a junior and senior level Quality Control Analyst III/ Document Control. Both of these roles will be working in the Quality department to support finished product testing activities in accordance with Good Manufacturing Practices (GMP) standards and FDA/ISO regulations (FDA’s Quality System Regulation and ISO 13485). Functions will include record review, product release, and document control.
- Performs and documents laboratory testing of finished product per Procedure.
- Conducts data analysis according to established methods and product specifications.
- Perform laboratory and equipment maintenance/ calibration activities as instructed.
- Review records and documents, for completeness and compliance with QSR and ISO requirements.
- Review batch record to support release of raw materials, work in progress and final products. This includes reagents, components and instrumentation-related products,
- Support the Material Review Board, for the assessment and disposition of non-confirming materials and closure of non-conformance and deviation reports.
- Participate in the internal auditor program.
Bachelor’s degree in scientific, quality system, or related discipline, with practical experience in a regulated manufacturing environment or equivalent experience.
Experience working in a biological lab is preferred.
Computer skills, e.g., word, excel, access, Microsoft project electronic documentation systems, ERP systems.
Must be able to work in a high-throughput, fast-paced environment
Excellent verbal and written communication skills are essential.
Understanding the Design of Experiments, root cause analysis, failure analysis, and general troubleshooting principles.
Ability to work in an office environment
Ability to list up to 20 lbs.
For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.