We are seeking a Quality Assurance (QA) Consultant - Specializing In CSV to become an integral part of our team!
** Chemical, Mechanical, Electrical engineering required (Bachelors of Science Degree)
** 5 + years Computer Systems Validation required (minimum)
** additional 5+ years working as QA consultant for Pharmaceutical, Biotechnology, Device Manufacturing Company (west coast preferred).
** direct experience with CSV review/approval, SAP, Doc Control Systems, QC Systems, LIMS, DCS, MES, BMS systems
- Provide QA guidance for Part 11, CFR Part 210, 211, 820 and related regulations to project teams
- Assist in Validation planning, risk assessment, requirements development/approval
- Assist in managing and reviewing validation deliverables.
- Assist in developing and reviewing SOPs, manufacturing work instructions.
- Familiar with all business processes within pharmaceutical, biotechnology, device manufacturing processes
- Engineering degree with 10+ years validation AND QA consulting experience, with solid references
- Previous experience in software development, quality assurance, or other related fields
- Familiarity with relational databases such as MySQL, Oracle, and SQL Server
- Experience with all business, QC, QA, manufacturing, and facilities systems supporting Pharmaceutical, Biotechnology, and Device manufacturing
- Strong root-cause analysis skills
- Deadline and detail-oriented
Role: Quality Assurance QA Consultant -Specializing - CSV
Location: San Francisco,
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