Quality Control Associate
- Years of working:2+ years of relevant experience
- Working place:Los Angeles, CA
- Recruiting number:No limit
- Education background：BS/BA in Life Sciences or related field
- Affiliate department：LA
Quality Control Associate
TCRCure is a clinical-stage biotechnology startup that brings novel TCR-T and CAR-T cell therapies to patients. We focus on treating solid tumors in global patient populations with few treatment options. Over the past 3 years, we have launched our first 3 generations of T cell therapies, and we need YOUR help to launch the next one.
Currently, TCRCure is seeking a highly motivated Quality Control Associate to join our Los Angeles QC team. Come help establish our QC program as we launch our first wave of cell therapy trials. We are looking for someone who can be an integral part of our quality control program as we build protocols and procedures to support the transition into GMP clinical production. This position will be based in Los Angeles, CA and the candidate will report the Quality Control Manager.
Responsibilities and Duties
• Perform in-process and routine Environmental Monitoring in ISO 8, ISO 7 and ISO 5 environments.
• Perform cell-based assays for lot release and stability.
• Perform QC testing of raw materials.
• Participate in validation/qualification activities.
• Maintain reference cell lines.
• Initiate, perform, and document laboratory investigations and non-conformances.
• Review/analyze data with respect to specifications, validity criteria, alert limits.
• Share general laboratory responsibilities, including equipment maintenance and calibration, housekeeping, and other lab support functions.
• Maintain sample logs to ensure timely testing and tracking of all samples.
• Adhere to good documentation practices to ensure data integrity and traceability.
• Organize and manage data relating to environmental monitoring and product testing.
• Maintain, revise and initiate Standard Operation Procedures, study protocols and reports.
• Work cross-functionally with Research and Manufacturing teams.
• Other duties as assigned.
• BS/BA in Life Sciences or related field.
• 2+ years of relevant experience within a Quality Control setting.
• Experience in GMP manufacturing and aseptic processing.
• Proficient hands-on laboratory skills (pipetting, dilutions, titrations, etc.).
• Proficiency in Outlook, Excel and other required computer applications.
• Must be able to gown for an ISO 7 cleanroom environment and work under aseptic conditions in an ISO 5 environment.
• Strong communication and interpersonal skills.
• Excellent organizational and writing skills, with a dedication to quality and compliance.
• Comfortable with the fast-paced, diverse environment of a startup company
If you are interested in applying for this opportunity, please submit your resume and cover letter. All submissions will be evaluated, and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.
TCRCure Biopharma provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. TCRCure Biopharma complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.