Job Description
Position Title: Quality Control Associate I
Work Location: South San Francisco, CA, USA, 94080
Assignment Duration: 12 Months
Work Arrangement: On-site (5 days a week)
Position Summary:
The job responsibility within the PTDA Bioassay US Testing Group is to perform biochemical/immunological and cell-based assays in support of clinical and to-be-marketed products. The candidate will support process development, product characterization, stability, and lot release testing with established procedures in a cGMP environment.
Key Responsibilities:
• Responsibilities include, but are not limited to, compliance review and release of assay data (electronic and paper-based), preparing reagents, presenting results, and monitoring assay quality.
• Expectations include Good Documentation Practices, demonstrating ALCOA+ principles, data integrity, routine lab maintenance, supporting 5S, and following EHS safety practices.
Qualification & Experience:
• B.S. in Biological Sciences with at least 1-2 years of relevant experience in Quality Control
• Hands-on experience with performing immunological or cell-based assays
• Experience with aseptic cell culturing and cGMP knowledge is required
• Ability to work independently as well as with a team, handle multiple projects, demonstrate initiative while maintaining exceptional attention-to-detail
• Demonstrate effective verbal and written communication skills in a fast paced environment
• Required proficiency in computer applications, data management, and electronic documentation systems.
Prior experience with GxP-compliant systems such as global SoftMax Pro, Single LIMS, and Veeva QMS is highly preferred.
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 25.00/hr.