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Quality Assurance Documentation Specialist

Revolution Medicines

Redwood City, CA, US
  • Job Type: Full-Time
  • Function: Engineering QA
  • Industry: Biotechnology
  • Post Date: 07/08/2024
  • Website: www.revmed.com
  • Company Address: 700 Saginaw Dr, Redwood City, California 94063, US

About Revolution Medicines

REVOLUTION Medicines discovers and develops new drugs that harness the therapeutic potential of frontier oncology targets on behalf of cancer patients.

Job Description

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.  The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

Revolution Medicines is seeking a motivated individual with a pharmaceutical quality assurance background to play a   critical role as QA Documentation Specialist and provides quality oversight on processing of all internal & external GxP documentation at RevMed. This position reports to the Manager of GxP Documentation and Training

  • Perform duties related to and maintain the document control system consisting of product related operational documentation, quality manual, external documentations, standard operating procedures, and work instructions.

  • Initiate and track all incoming, in-process and completed document change controls, associated supporting documentation and following up to ensure the changes are completed and documentation is properly closed out and released.

  • Create and administer the Controlled Documents process/procedure.

  • Provide guidance on document control practices and procedures to all functional departments.

  • Support the maintenance and improvement to quality systems processes, as needed.

  • Ensure compliance to RevMed’s processes/procedures, policies and GxP standards.

  • Assist in running weekly/monthly training and other document control reports.

  • Works with cross functional stakeholders to ensure follow-up of quality issues.

  • Provide inspection readiness support including front room and backroom.

  • Other tasks as assigned by the management.

 Required Experience, Skills, and Education:

  • 5+ years of relevant experience in bio-pharmaceutical environment Quality Systems

  • Demonstrates working knowledge of including but not limited to: cGMPs, applicable ICH Guidelines, Eudralex Volume 4, etc.

  • Bachelor of Science in Life Sciences, Engineering, or related discipline.

  • Ability to work in a team environment, manage multi-tasking, and discipline in completing tasks on schedule.

  • Excellent written and verbal communication skills.

  • Proficient in Microsoft Office skills (WORD, Excel, PowerPoint).

  • Working knowledge of eDMS (Veeva (a plus), MasterControl, TrackWise, ComplainceWire etc).

Preferred Skills:

  • Direct experience with Veeva Quality Vault eDMS/eQMS/eLMS.

  • Pharma/Biotech Commercial experience a plus.

The expected salary range for this role is $95,000 to $120,000. An individual’s position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. Base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.

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