California All, CA 94949 US
R&D Partners is seeking to hire an Engineer 2 Global QA CSA in Novato, CA.
Benefits of this role:
Benefits + 401k
Your main responsibilities as an Engineer 2 Global QA CSA:
Provide CSQA expertise and oversight of QC/BAS Analytical Instrument, Enterprise, Operations/Supply Chain and Quality computerized system validation from a quality assurance perspective to ensure quality and compliance requirements are met.
Provide oversight and support of the Quality Change Management process and activities associated with the implementation of new GxP computer systems and/or changes to existing validated computer systems.
Provide guidance and support root cause analysis on CSV validation issues and discrepancies. Support investigation of CSV defects and quality records (deviation, CAPAs).
Apply Risk-based methodologies across the computerized system lifecycle.
Provide guidance and QA oversight for SDLC documents like User Requirements, Specifications and Validation/Qualification protocols and test scripts..
What we are looking for in an Engineer 2 Global QA CSA:
BS in a Computer Science or Engineering field or equivalent experience
3 to 5 years experience in CSV in the Life-science/regulated industry
3 to 5 years working in the Quality area in biotech or pharma
Experience in Deviations, CAPAs and Change Control Management
Strong knowledge and implementation experience on industry regulations (e.g., 21CFR210, 211, 820, Part 11, Annex 11, ICH Q9, Q10) and guidance s (e.g., ISPE GAMP, MHRA)
Why Choose R&D Partners?
Refer a Friend bonus
$54.42 - $68.02 (Dependent on Experience)
R&D Partners is a specialist employment agency and recruitment business providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal opportunity employer.