Quality Assurance Specialist
4 weeks ago
About the Role
BioMarin's 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. We are seeking a Quality Assurance Specialist to support Quality Systems related to operations, product specification change controls and batch release processes.
Key Responsibilities
- Create and/or revise product specification documents, following MAA, BLA, CTA, IND and/or IMPD filings, in BioMarin's controlled document management system (Veeva).
- Initiate and set-up change control workflows for product specification revisions in Veeva and BioMarin'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.
Requirements
- Minimum 3-5 years of experience in a Quality, Compliance, and/or Regulatory setting.
- 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.
Education
- Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical engineering, chemical or biological sciences) is required.
- Advanced degree preferred.
About BioMarin
BioMarin is a global biotechnology company that develops and commercializes innovative therapies for rare and serious diseases. Our 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.
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