Details:
- Compensation: $90,000 - $115,000k
- Benefits: Medical, Dental, Vision
- Employment Classification: Direct Hire
- Status: On-Site
- Job ID: 20734
Lead QC Analyst, Raw Materials Cell Therapy
How You Will Make an Impact:
How You Will Make an Impact:
- Support QC Raw Materials program by performing raw material inspection/sampling (as needed)/approvals per written procedures
- Assist in completing material onboarding assessments, classifications and safety assessments (as applicable)
- Sample management activities-maintain quarantine, released, retain, and testing material inventory (spreadsheets)
- Maintain QC RM monthly metrics
- Perform risk assessments, create and develop material specifications and testing requirements (as needed)
- Develop programs for raw material qualification and monitoring of compendiaI updates
- Support material testing for external contract testing laboratories (quotes, shipping and test results, etc.)
- Support QC for material Supplier Change Notifications and attend Material Review Board meetings, as needed
- Write and/or review protocols, test methods, and reports in support of analytical methods for cell therapy products
- Perform non-routine/routine QC testing for analytical methods in support of cGMP manufacturing of cell therapy products (in-process, raw material, final product or stability) as needed
- Support analytical equipment installation and qualification, ensuring 21 CFR Part 11 compliance, as needed
- Participate as raw material method subject matter expert (SME) in investigations, deviation, change controls, and CAPAs to support cGMP operations
- Work collaboratively with cross functional departments including but not limited to Warehouse, Supply Chain, Supplier Quality, Quality Assurance, and Program Management
- May interact with external partners on technical matters in relation to raw materials or analytical methods
- Write/revise QC specific material specifications, procedures and protocols
- Possess the ability to evaluate various Quality Certificates of chemicals/raw materials/packaging components
- Adhere to compliance of Warehouse area in terms of Isolation of Quarantine and Released materials
- Other duties as assigned
- Bachelor's degree in scientific discipline
- 5+ years of GMP QC laboratory experience (raw material testing/release is a plus)
- Knowledge in ANSI.ASQ Zl.4 sampling plans
- Knowledge of analytical method industry guidances (e.g., ICH)
- Experience in pH, osmolality, or identification procedures (experience in qPCR, Flow Cytometry, ELISA, and/or cell-based assays is a plus)
- Excellent/Effective written and verbal communications skills
- Developed troubleshooting and problem-solving skills
- Ability to adhere to timelines for testing and reporting of data
- Possess strong organization, communication, writing, people skills/teamwork, and detail-oriented