Quality Control Supervisor - Cell Therapy (PM Shift)
About The Position
The Quality Control Supervisor - Cell Therapy (PM Shift) will be responsible for the supervision of Cell Therapy Quality Control (QC) third shift personnel, assays, and equipment in support of the production, release, and distribution of Cell Therapy products. This role works in cooperation with the Quality Assurance groups to ensure client methods are successfully executed in the QC lab for use in support of Cell Therapy Operations. This is an on-site position located in Pearland, TX, with an available shift of Night shift 8:00 PM - 6:30 AM to ensure continuous quality control support. Shift differentials are included for night shift and weekends.
Requirements
- Bachelor's degree in related Science field of study.
- 5 - 10 years of experience in Cell Therapy.
- Advanced skills and experience in Quality Control.
- Demonstrated knowledge in biological, cell-based assays including flow cytometry.
- Experience with method validation and technology transfer preferred.
Responsibilities
- Supervision of the Cell Therapy PM team.
- Acts as an advisor when determining how to meet schedules and/or resolving technical problems.
- Reviews testing and laboratory records for accuracy and compliance with cGMP and Lonza policies and principles.
- Partners with QC Cell Therapy manager and QC Cell Therapy Flow Cytometry supervisor to ensure adequate coverage for in-process control testing.
- Leads, mentors, and coaches staff through routine one-on-one meetings, team meetings, and effective performance management.
- Sets and delivers on individual and team goals that support the department and site strategy.
- Writes, reviews, and/or approves SOPs, sampling plans, protocols, and specifications.
- Prepares responses to audits, deviations, out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA).
- Actively works to ensure responses are completed on-time and escalates roadblocks to completion and provides potential solutions.
- Develops training plans and performs identification and remediation of training gaps.
- Should possess knowledge of how to execute team methods/procedures and operate equipment.
- May need to support and/or execute analyst tasks on a non-routine basis.
Benefits
- Performance-related bonus.
- Medical, dental and vision insurance.
- 401(k) matching plan.
- Life insurance, as well as short-term and long-term disability insurance.
- Employee assistance programs.
- Paid time off (PTO).
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What This Job Offers
Job Type
Full-time
Career Level
Manager
