Novato, CA

External Quality Associate I

Quality Associate 1
Location: Novato, CA. (Hybrid – 2 days onsite)
12 month assignment (Great potential to extend or convert)
Pay Rate: $43/hr.
On behalf of our client, a leading pharmaceutical company that specializes in the development of therapeutics for patients with life threatening rare genetic diseases.  We are seeking a dedicated Quality Associate 1 that will report to the Quality Manager and will be responsible for supporting quality systems related to operations, product specification change controls, and batch release processes.  This position will require interaction with multiple levels in quality, Regulatory Affairs, Manufacturing, Supply Chain, Materials Management, and Contract Manufacturing Operations.
 
Responsibilities:

  • Create and/or revise product specification documents following MAA, BLA, CTA, IND, and/or IMPD filings in company's controlled document management system (Veeva).
  • Initiate and set up change control workflows for product specification revisions in Veeva and company's management system. 
  • Coordinate Veeva change control workflows for the 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.

Experience and Skills:

  • Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical engineering, chemical or biological sciences) is required.
  • Minimum 3-5 years of experience in a Quality, Compliance, and/or Regulatory setting.
  • Proficiency with eQMS (Veeva), LIMS, Oracle EBS, eCDMS (Veeva), and Office365 preferred.

  • Max. file size: 300 MB.