Quality Assurance Specialist in West Menlo Park, CA at Volt

Date Posted: 10/17/2020

Job Snapshot

Job Description

Description:

  • Performs data and document audits to ensure application integrity, accuracy, consistency and completeness. Prepares and issues final audit reports summarizing findings and noting corrective action.
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
    • Reviews Manufacturing documentation by obtaining all lot history records and non-conforming material reports and ensuring that they are compiled in accordance with internal procedures.
    • Tracks Documentation discrepancies by maintaining a mechanism by which discrepancies with manufacturing documentation can be tracked to determine trends, etc.
    • Notifies Manufacturing personnel of documentation issues by providing feedback immediately upon discovery of issues, and, on a periodic basis, informing manufacturing personnel in a more formal manner of discrepancies with manufacturing documentation.
    • Confines discrepant materials by maintaining a Quarantine area whereby discrepant materials are physically located until they are resolved and can be released.
    • Releases product by performing the necessary transactions in SAP in the sterile cycle to release product upon receipt of the Product Release Authorization and completion of LHR review.
    • Reviews and approves Design History Files by obtaining and verifying the contents of DHFs and approving the Engineering Order authorizing release into the Archive department.
    • Advises Manufacturing personnel and project leaders by functioning as the "expert" in the area of documentation compliance.;
    • Coordinates Clinical product by completing appropriate paperwork to release clinical product to approved sites.

Requirements:

  • Having a significant years of experience in a similar position.

Volt is an equal opportunity employer.