What are the responsibilities and job description for the Scientist I, Analytical position at Astellas?
AIRM is seeking a highly motivated individual with strong organizational skills to join us as a Quality Control Scientist . This position provides Quality Control qualification, validation, testing support for AIRM cell therapy products. Looking for strong GMP and cell culture background with method validation and quality control testing experience.
Essential Job Responsibilities:
Perform routine in-process and release QC testing of AIRM cell products.
Oversee and execute analytical method qualifications, validations and transfers including drafting technical protocols, reports and assay troubleshooting.
Maintain, calibrate and operate equipment and instruments supporting Immunofluorescence, Flow Cytometry, and PCR assays.
Track and test products according to stability protocols.
Work with internal and external resources to maintain lab in a audit ready GMP state
Monitor and trend QC data.
Support validation and testing of cell bank programs.
Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release and stability.
Perform shipment of materials for QC testing to contract labs and perform data review.
Author, revise and review SOPs, qualification/validation protocols and reports.
Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations, Change Requests and CAPAs related to analytical procedures.
Monitor the GMP systems currently in place to ensure compliance with documented policies.
Assist in the preparation of reports and data packages for interactions between AIRM and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.
Perform QC lab duties and technical projects as required.
Essential Job Responsibilities:
Perform routine in-process and release QC testing of AIRM cell products.
Oversee and execute analytical method qualifications, validations and transfers including drafting technical protocols, reports and assay troubleshooting.
Maintain, calibrate and operate equipment and instruments supporting Immunofluorescence, Flow Cytometry, and PCR assays.
Track and test products according to stability protocols.
Work with internal and external resources to maintain lab in a audit ready GMP state
Monitor and trend QC data.
Support validation and testing of cell bank programs.
Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release and stability.
Perform shipment of materials for QC testing to contract labs and perform data review.
Author, revise and review SOPs, qualification/validation protocols and reports.
Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations, Change Requests and CAPAs related to analytical procedures.
Monitor the GMP systems currently in place to ensure compliance with documented policies.
Assist in the preparation of reports and data packages for interactions between AIRM and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.
Perform QC lab duties and technical projects as required.
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