Quality Control Flow Cytometry Specialist from Joulé
Exton, PA
About the Job
Title: Quality Control Flow Cytometry Specialist
Location: Exton, Pa
Schedule: M-F 8am-4:30pm
Type: 6 month contract to hire based on performance
Start date: Immediate
Our client is a late-stage cell and gene therapy company seeking a senior-level candidate who is looking for career growth into a management position. The quality control group is heavily involved with the R&D group as they work together to create transformative therapies that improve the lives of people living with genetic diseases. The ideal candidate will possess a robust technical proficiency encompassing PCR, flow cytometry, cell culturing, and ELISA methodologies
Responsibilities:
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Location: Exton, Pa
Schedule: M-F 8am-4:30pm
Type: 6 month contract to hire based on performance
Start date: Immediate
Our client is a late-stage cell and gene therapy company seeking a senior-level candidate who is looking for career growth into a management position. The quality control group is heavily involved with the R&D group as they work together to create transformative therapies that improve the lives of people living with genetic diseases. The ideal candidate will possess a robust technical proficiency encompassing PCR, flow cytometry, cell culturing, and ELISA methodologies
Responsibilities:
- Execute Analytical Test Methods for bulk intermediate testing and final product release testing.
- Execute testing for raw materials.
- Author and revise QC SOPs and ATMs as necessary to maintain compliance.
- Review of Quality Control raw data for accuracy, completeness, and compliance with effective SOPs to ensure the strength, identity, safety, purity, and quality of the product.
- Timely response to Out of Specification (OOS) results, including notification to area supervision.
- Communicate with the individual Operations Departments (Manufacturing, Quality Assurance, Facilities) to ensure that Company objectives are met on schedule.
- Maintain housekeeping in the laboratories.
- Assist the Quality Control Supervisor in daily operations, as needed.
- Authoring and/or executing protocols and generating technical reports.
- Analytical test method qualification and validation.
- Equipment qualification and preventative maintenance.
- Training of other employees.
- Completion of thorough Laboratory Investigation Reports (LIRs) to ensure that potential problems and root causes are identified, impact is assessed, and actions to prevent recurrence are considered and implemented.
- Minimum Bachelor of Science degree in a scientific discipline
- 7-10 years’ experience in Quality Control within biologics
- Strong skills in flow cytometry, ELISA, and PCR
- Knowledge of laboratory skills are required
- Knowledge of Current Good Manufacturing Practice and Industry standards
- Familiarity with analytical equipment including UV absorbance plate readers, Flow cytometers, microscopes, automated cell counters, and PCR thermal cyclers.
- Experience in aseptic processing and mammalian cell culture production
- Must be open to occasional off shift and weekend work.
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