Senior QC Associate Job Description Template
Our company is looking for a Senior QC Associate to join our team.
Responsibilities:
- Perform log-based cell bank inventories;
- Request and coordinate cell bank vial shipments to/from offsite biorepository;
- May generate and/or revise Quality Technical Agreements with contract testing labs and contract cell bank manufacturers;
- Organize and track contract testing and cell bank testing/production activities;
- Generate legal contract requests and purchase orders for contract testing and cell bank testing/production;
- Maintain tracking spreadsheets/databases for contract testing lab activities and information;
- Support regulatory agency, partner and QP inspections;
- Assist with management of in-country testing and provide updates to team and management;
- Liaise between contract laboratories and internal groups;
- Support regulatory filings;
- Assist with shipment of samples and reagents to contract labs;
- Provide support in organizing QC contract testing and cell bank production activities;
- Manage and maintain good relationships with contract testing lab partners;
- Initiate change requests (CR) for new cell bank production and SOP revisions using TrackWise system;
- Initiate change requests (CR) for new cell bank production and SOP revisions using system.
Requirements:
- At least 4 years in a cGMP laboratory; quality control experience required;
- Knowledgeable and conversant concerning 21CFR, USP, EP, and ICH regulatory guidelines;
- Proficiency in MS Applications;
- Experience in dealing with contract testing laboratories is highly preferred;
- Well-developed laboratory skills for analysis of pharmaceuticals and biopharmaceuticals;
- Excellent project management and organizational skills;
- B.S./B.A. degree with 4 years of experience in pharmaceutical industry, including some work in a laboratory setting.