Lead QC Analyst, Raw Materials, Cell Therapy
About The Position
The Quality Control/ Raw Material Lead Analyst will be responsible for working under guidance of a QC Manager and He/she will support the inspection and release of various incoming raw materials for use in the manufacturing of cell therapy products, including authoring material specifications, in compliance with all applicable quality systems and current cGMPs. He/she may also support routine QC laboratory and testing support activities as needed for analytical method analysis. He/she will be responsible for writing protocols, standard operating procedures (SOPs), and reports in support of analytical testing, as needed.
Requirements
- 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
- Experience working in a team environment, facilitating a team approach, and communicating effectively
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
251-500 employees
