Quality Assurance QA Consultant -Specializing - CSV

Celere, Inc.
San Francisco, CA
Jul 15, 2017
Administrative Jobs
Technology, Database Administration
Jobs Outside Higher Education
Businesses & Consultants, Software & Technology
Institution Type
Outside Academe

Job Description

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

San Francisco, CA


Sun, 18 Jun 2017 10:00:34 PDT