Skip to content

Job Openings

Engineer 2 Global QA CSA

Novato, CA 94949

Posted: 01/08/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 590997 Is job remote?: No Country: United States

Job Description


Duties:
 
  • 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.
  • Responsible for the authoring and development of Periodic Reviews Reports for computerized systems across the company.
  • Provide quality oversight to support and follow the company's Data Integrity Program.
  • Establish and sustain the company's computer system validation global policies and standards that incorporate industry best practices and are health authority compliant.
  • Partnering with internal and external IM, QA, and Development Sciences teams; sharing information to increase the collective understanding of QA and Data Integrity programs.
  • Knowledge of industry standards; 21 CFR Parts 210, 211, 11, 820, EU Annex 11, ISPE GAMP5, as it relates to computer systems used at the company.
  • Ensuring alignment of processes, procedures, and methods across multiple organizations (internal and external).
  • Authoring and /or revising SOPs.
  • Authoring and / or revising validation documents and protocols.
  • Administer applicable electronic systems.
  • Assist as needed in audits and inspections.
  • Contribute to projects related to CSQA improvements and system reliability.
  • Development, execution, and approval of change control records.
  • Support the Compliance team on computerized system audits to ensure compliant vendor/supplier management program and services.
Requirements:
  • 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)
  • Good knowledge and implementation experience on Data Integrity requirements (e.g., ALCOA & ALCOA+)
  • Experience with Computer Systems Periodic Reviews
  • Experience with Veeva QMS and Quality Docs
  • Experience with Office 365
  • Experience with SAP desirable
  • Experience with ALM desirable  

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About Novato, CA

Discover Exciting Job Opportunities in the Vibrant Novato, California Area! Novato, nestled in Marin County and conveniently located near San Francisco, offers job seekers a perfect blend of suburban charm and urban excitement. With its picturesque surroundings, proximity to the wine country, and access to stunning parks like Stafford Lake Park and the Marin Museum of Contemporary Art, Novato provides a dynamic backdrop for career growth. Enjoy the renowned cuisine at spots like Boca Tavern or trek the beautiful trails at Mount Burdell. Don't miss the Novato Theater Company productions or catch a game at the Novato Community Athletic Fields. Start your career journey in Novato today and experience the magic this bustling town has to offer.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.