The Opportunity
Conduct quality control testing on products and materials
Analyze test results and report deviations
Ensure compliance with GMP and regulatory standards
Document quality control procedures and findings
Assist in troubleshooting and root cause analysis
Who You Are
- 5-10 years of experience, specifically BioAssay or Cell Culture required
- Strong problem-solving skills
- Excellent communication abilities
- Knowledge of industry best practices
Preferred
Experience with laboratory GMP testing required
Additional Notes :
Key Responsibilities :
Maintain mammalian cell lines, including transferring between incubatorsRun plate-based, cell-based assays , and multi-channel assaysConduct ELISA and BioAssay testing, including different cell culturesInitiate deviations and perform troubleshootingEnsure adherence to GMP and QC standardsWork with Veeva document system and other QA record platformsKnowledge of drug and antibiotic testing at 80°CRequired Skills & Experience :
Minimum 5-10 years of experience in GMP environments (3-4 years may be considered if in-depth BioAssay knowledge)Bachelor's or Master's degree preferred; high school minimum acceptableExperience with cell culture, maintaining cell lines, ELISA assays, BioAssay, cell-based assays , and different cell culturesFamiliarity with QMS, Nextlab tools, and electronic documentation systemsExperience in assay panel testing and binding / curve analysisTop 3 Must-Have Skills :
Cell culture - maintain cell linesELISA assayBioAssay