Control Material Analyst
A biotech manufacturing company in Sunnyvale, CA is looking for a Control Material Analyst to perform qualification and manufacturing of template materials used in internal product testing and raw material for product build according to established procedures. This position will be working in operations facility to support control material production as well as control material stability program activities in accordance to GMP standards and FDA/ISO regulations. The successful candidate will have working knowledge of laboratory procedures, techniques, and methodologies, especially in handling bacterial cells, nucleic acid, viruses, etc.
- Perform reference control material qualification/production
- Perform qualification/production of template material work order
- Aliquoting and labeling of template/control reference materials
- Report non-conformance material (initial observation of non-conformance)
- Participate in test method validation activities
- Revise and update minor changes to testing procedures, work instructions, and worksheet for correction or process improvement
- Assist in batch record review
- Evaluate/Maintain proper control material usage rate and inventory to support operation testing needs
- Assist in stability testing or activities as needed
- Assist/Support in equipment maintenance/calibration activities if needed
- Perform other duties as assigned or requested.
Bachelor in a scientific discipline, preferably in molecular biology/biochemistry field.
Minimum of 1 year of laboratory testing experience in manufacturing or operations environment.
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 as well as external teams.
Strong multi-tasking and attention to details skills.
Experience in handling biological and chemical materials.
Proficiency with Microsoft office tools.
Ability to lift up to 20 lbs.
Working knowledge of PCR is highly preferred.
Knowledge of microbiologic and analytical chemistry techniques and protocols are a plus.
IVD experience is preferred.
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.