Senior QC Associate

Novato, CA 94949

Posted: 06/17/2019 Employment Type: Contract Industry: Quality Job Number: 6399

Duties: 

This position will assist with management of QC contract testing and production related activities. Key responsibilities may include:
  • Provide support in organizing QC contract testing and cell bank production activities.
  • Serve as point of contact between contract laboratories and internal Client groups.
  • Assist with management of in-country testing and provide updates to team and management.
  • Establish effective communication and collaborative relationships with other functional groups and key stakeholders.
  • Maintain tracking spreadsheets/databases for contract testing lab activities and information.
  • Provide updates on testing status to QC labs and management.
  • Serve as point of contact for contract laboratories and internal Client groups.
  • Attend meetings as QC Contract Laboratory Management representative and provide updates and input as necessary.
  • Generate and/or revise Quality Technical Agreements with contract testing labs and contract cell bank manufacturers.
  • Generate legal contract requests and purchase orders for contract testing and cell bank testing/production.
  • Initiate change requests (CR) for new cell bank production and SOP revisions using TrackWise system.
  • Prepare monthly summaries of contract laboratory activities and metrics.
  • Perform contract lab performance evaluations and present evaluations during contract lab review forum.
  • Assist in the performance of log-based and physical cell bank inventories.
  • Request and coordinate cell bank vial shipments to/from offsite biorepository.
  • Assist with shipment and samples and reagents to contract labs.
  • Support regulatory filings requests
  • Support regulatory agency, partner and QP inspections.

Skills:    
  • At least 6 years in the biopharmaceutical industry, with at least 2 years in a cGMP laboratory; quality control experience preferred.
  • Experience in dealing with contract testing laboratories is highly preferred.
  • Managerial/Supervisor experience is a plus.
  • Demonstrated ability to perform most tasks with minimal supervision given general instructions on routine work and instructions on new assignments.
  • Excellent organizational and project management skills.
  • Proficient in MS applications - Excel, PowerPoint, Word.
  • Knowledgeable and conversant concerning 21CFR, USP, EP, and ICH regulatory guidelines.

Education:          
  • B.S./B.A. degree with 6 years of experience in biopharmaceutical industry.
  • Thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies.
  • Excellent written and verbal communication skills.

Skills:    

  • At least 6 years in the biopharmaceutical industry, with at least 2 years in a cGMP laboratory; quality control experience preferred.
  • Experience in dealing with contract testing laboratories is highly preferred.
  • Managerial/Supervisor experience is a plus.
  • Demonstrated ability to perform most tasks with minimal supervision given general instructions on routine work and instructions on new assignments.
  • Excellent organizational and project management skills.
  • Proficient in MS applications - Excel, PowerPoint, Word.
  • Knowledgeable and conversant concerning 21CFR, USP, EP, and ICH regulatory guidelines.

Education:          

  • B.S./B.A. degree with 6 years of experience in biopharmaceutical industry.
  • Thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies.
  • Excellent written and verbal communication skills.
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