Senior QC Associate, Potency
$68,300–$126,900 year
On-site · Hillsboro, Oregon, United States
Job Summary
Senior QC Associate, Potency responsible for leading bioassay testing within Roche Genentech’s Hillsboro QC operations. Acts as SME for Bioassay Operations, mentors junior analysts, and coordinates scheduling and testing activities. Implements QC policies in a cGMP environment, performs and reviews a range of bioassays across in-process, drug product, finished product, raw materials, and environmental monitoring. Troubleshoots assay failures and equipment issues, supports method validation/transfer and investigations (OOS/OOT/ Deviations/CAPAs), ensures instrument maintenance, and supports cGMP audits and Health Authority inspections. Requires extensive experience with cell culture, assay development and data analysis, strong technical writing, and ability to travel as needed.
Required Qualifications
- Bachelor’s Degree with 5-7 years experience in a cGMP or similarly regulated environment; Master’s Degree with 3-5 years experience; PhD/JD with 0-2 years experience
- Significant experience executing cell culture and bioassays in GMP QC labs
- Experience with cell-based assays (reporter gene, proliferation, cytotoxicity, apoptosis, ADCC/CDC) and immunoassays
- Experience in method validation and transfer, troubleshooting, and data analysis (parallel line analysis, 4-PL/5-PL)
- Proficiency with SoftMax Pro, JMP, LIMS, ELN, TrackWise, Veeva Vault
Additional Requirements
- None specified
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