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External Quality Associate I

Novato, CA 94949

Posted: 06/06/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 607880 Is job remote?: No Country: United States

Job Description


We are a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.

A high-level of initiative, energy, and motivation are key role requirements, as well as organizational skills and the ability to motivate others.

The Quality Associate 1 reports to the Quality Manager and is responsible for supporting Quality Systems related to operations, product specification change controls and batch release processes. This position requires interaction with multiple levels in Quality, Regulatory Affairs, Manufacturing, Supply Chain, Materials Management, and Contract Manufacturing Operations.

The Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These individuals build and maintain the company's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

 

KEY RESPONSIBILITIES
  • Create and/or revise product specification documents, following MAA, BLA, CTA, IND and/or IMPD filings, in the controlled document management system (Veeva).
  • Initiate and set-up change control workflows for product specification revisions in Veeva and the company's quality management system.
  • Coordinate Veeva change control workflows for review and approval of product specification revisions.
  • Monitor and ensure document implementation timelines.
  • Monitor backlog in associated trackers.
  • Generate custom Certificates of Analysis to support lot release, new market applications, annual product reviews, and/or market renewals.
  • Ensure all individual training and group-specific guidelines are kept current.
  • Provide assistance with training new staff.

EXPERIENCE
  • Minimum 3-5 years of experience in a Quality, Compliance, and/or Regulatory setting.
  • Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical engineering, chemical or biological sciences) is required.
  • Advanced degree preferred.
  • Strong attention to detail, organization and communication skills.
  • Ability to maintain organization of a large volume of data in a systematic manner
  • Proficiency with computer systems (Microsoft Office Suite).
  • Proficiency with eQMS (Veeva), LIMS, Oracle EBS, eCDMS (Veeva) and Office365 preferred.

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.

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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.