- Create and/or revise product specification documents, following MAA, BLA, CTA, IND and/or IMPD filings, in controlled document management system (Veeva).
- Initiate and set-up change control workflows for product specification revisions in Veeva and 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.
- 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.
- REGULATORY DOCUMENT REVIEW
- Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical engineering, chemical or biological sciences) is required.
- Advanced degree preferred.
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Quality Associate I - Novato, United States - Randstad Life Sciences US
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Description
Summary:
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.
Job Responsibilities
Experience:
Required
Education: