- Create or update product specification documents in the document management system (Veeva) following specific regulations.
- Manage change control processes for product specifications in Veeva and the internal quality system.
- Coordinate review and approval workflows for specification changes.
- Ensure timely implementation of documents.
- Track associated backlogs efficiently.
- Prepare Certificates of Analysis for various purposes.
- Keep training guidelines up to date and assist in new staff training.
- BS degree in a technical field (Physical Engineering, Chemical, or Biological Sciences).
- 3-5 years of experience in Quality, Compliance, or Regulatory roles.
- Document review and management experience.
- Strong attention to detail, organization, and communication.
- Proficiency in using computer systems and software.
- Experience with Veeva, LIMS, Oracle EBS, and Office365 is a plus.
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Quality Associate - Novato, United States - Randstad Life Sciences
Description
Quality Associate Position at a Leading Company
Are you looking for a new opportunity as a Quality Associate to be part of a dynamic team? This role involves working on quality systems, product specification changes, and batch release processes. You'll collaborate with various departments such as Quality, Regulatory Affairs, Manufacturing, and more.
Schedule/Shift: 1st shift, Monday to Friday, with 2 onsite days (Tuesday required)
Type of Position: Contract role for 1 year (until May 2025)
Key Responsibilities:
Requirements:
About the Company: Join a well-respected company known for its innovative work and positive industry reputation.
