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Posted: Saturday, September 16, 2017 5:40 AM

Job Description:/h3:
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
: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


• Location: San Francisco

• Post ID: 82214557 sf is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2017