Quality Control Analyst
A manufacturing company in Sunnyvale, CA is looking for a Quality Control Analyst to conduct routine finish, good product stability testing according to established procedures. This position will be working in Quality Control to support stability testing activities in accordance to GMP standards and FDA/ISO regulations. The position will also participate in validation testing and stability data discrepancies investigations activities. The successful candidate will have experience working in quality, have working knowledge of laboratory procedures, techniques, and methodologies.
- Hands on laboratory testing for Stability products.
- Generate reports and summaries, and other activities to support product stability trending.
- Perform validation testing to support stability test method transfer to QC.
- Initiate deviation/nonconforming documentations to address deviated processes.
- Interact with Development, Product Transfer, and Quality Engineer to resolve stability
- Participate/Perform investigations and compile data/summary/report to support conclusion.
- Revise and update SOP and testing procedures/worksheets.
- Review DHR/Batch Records
- Assist in control materials activities as needed.
- Perform other duties as assigned ore requested.
Bachelor in a scientific field, preferably in molecular biology/biochemistry discipline plus a minimum 2-5 years of quality control/manufacturing testing experience.
Experience working in a GMP compliance environment and working knowledge of FDA/ISO requirements.
Strong team player with excellent interpersonal and communication skills.
Able to work independently and interface effectively with multiple disciplines within groups and across departments.
Strong multi-tasking and attention to details skills.
Ability to develop solutions to solve problem.
Experience in handling biological and chemical materials.
Proficiency with Word, Excel, etc.
Working knowledge of PCR and microbiology laboratory experiences is highly preferred.
Knowledge of analytical chemistry techniques and protocols is a plus.
IVD experience is preferred.
Ability to lift 20 – 30 lbs.
For more than thirty 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.