Senior QC Associate
Marin Metro Area, CA
This position will assist with the management of QC contract testing and cell bank production related activities. Key responsibilities may include:
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 managment.
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.
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.
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