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Quality Engineer III
at Apex Systems, Inc.
San Francisco, CA

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· 4 year college degree; preferably a BS in Computer Science, Chemistry, Biology, Engineering Pharmacy, or Microbiology.

· Minimum of 8+ years of experience in Quality Assurance or related field such as regulated GxP environment in qualification/validation, documentation or compliance.

· Sound knowledge of the current regulatory requirements (21 CFR Part 11, EU GMP Annex 11 / 15, ICH, PIC/S) and Best Practices (GAMP5, etc.).

· Conducting or providing QA oversight of Equipment, Facility, Utility, Instrument qualification and Cleaning, Automated Process Controller, Qualification and Validation.

· Excellent communication capabilities and teamwork capacities.

· Proven ability to work in a global environment and on virtual teams.

· Experience with Veeva Vault, Waters Empower, LIMS is preferred.

· Solid understanding of Computer Systems Validation.

· Technical knowledge in Oracle, SQL Server, SQL, PL/SQL, Windows Servers, Webservers, Web Application, client/server, Cloud applications and SaaS models.

Major Job Responsibilities:

· Provide interpretation, guidance, and training for clients regarding qualification and validation requirements in GLP-, GCP- and GMP-regulated areas of an R&D organization.

· Author, Review / approve various qualification / validation plan documents, test strategies, test documents, summaries, and certification packages and associated deliverables as appropriate with minimal supervision.

· Compilation, review and approval of quality documents (Policies, Processes, Procedures, templates, formats etc.).

· Support CAPA activities related to validation and qualification.

· Provide guidance, direction, and support to peers.

Local candidate only for this position please.

VEVRAA Federal Contractor
We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.
We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.

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