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Specialist, Quality Assurance Operations

Novato, CA 94949

Posted: 09/28/2022 Employment Type: Contract Job Category: Quality and Compliance Job Number: 507970-1 Is job remote?: No Country: United States

Job Description


This position is responsible for performing QA inspection and disposition of GMP raw materials for use in Novato Manufacturing Operations, and supports other Quality functions in the warehouse. This position reports to Manager, QA Operations Raw Materials.

The responsibilities in the role include the following:
  • Perform Inspection, Review, and Disposition of incoming raw materials at the Novato GMP Warehouse(s)
  • Maintain electronic status control and data entry in Oracle EBS system for GMP raw materials.
  • Quality review and revision of BioMarin Raw Material Specifications and Standard Operating Procedures using the Electronic Document Management System, Veeva
  • Perform visual inspection and release of primary packaging components. This includes but not limited to, managing coordination of samples, and ensuring timely maintenance and calibration of inspection equipment.
  • Provide QA support to other QA raw materials activities: Control of rejected materials, deviation and change control support in TrackWise, and other Warehouse QA responsibilities, as assigned.
Requirements:
Associate degree (AA/AS) or equivalent in science related area, or Biotech certificate with 2+ years of experience in a biotech environment or other regulated industry preferred.
  • Strong communication skills—verbal and written, ability to work in a team environment
  • Experience with ERP and quality management systems
  • Proficient in Microsoft platforms
  • Attention to detail and ability to prioritize daily tasks

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.