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Senior QC Associate, cell bank

Marin Metro Area, California

Post Date: 06/20/2017 Job ID: JN -062017-19347 Industry: QC - Scientific
DUTIES:
This position will assist with the management of QC contract testing and cell bank production related activities.
  • Provide support in organizing QC contract testing and cell bank production activities.
  • Provide support in coordination of international shipments.
  • Liaise between contract laboratories and internal 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, key stakeholders, and external contacts.
  • Maintain tracking spreadsheets/databases for contract testing lab activities and information.
  • Organize and track contract testing and cell bank testing/production activities.
  • May 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.
  • Perform log-based cell bank inventories.
  • Request and coordinate cell bank vial shipments to/from offsite biorepository.
  • Assist with shipment of samples and reagents to contract labs.
  • Manage and maintain good relationships with contract testing lab partners.
  • Support regulatory filings.
  • Support regulatory agency, partner and QP inspections.
SKILLS:
  • At least 4 years in a cGMP laboratory; quality control experience required.
  • Experience in dealing with contract testing laboratories is highly preferred.
  • Well-developed laboratory skills for analysis of pharmaceuticals and biopharmaceuticals.
  • Demonstrated ability to perform most tasks with minimal supervision given general instructions on routine work and detailed instructions on new assignments.
  • Proficiency in MS Applications
  • Excellent organizational and project management skills.
  • Knowledgeable and conversant concerning 21CFR, USP, EP, and ICH regulatory guidelines.
EDUCATION:
  • B.S./B.A. degree with 4 years of experience in pharmaceutical industry, including some work in a laboratory setting.
  • 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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