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QA Junior Associate – Manufacturing
Office: Kiryat Gat, Israel | Location: On Site
- Company: Gamida Cell, LTD
- Posting Title: QA Junior Associate – Manufacturing
- Function: QA
- Division: Quality
- Location: Kiryat Gat, Israel – On Site
Gamida Cell is a leader in advanced cellular therapies and hematopoietic stem cell transplantation, with two FDA approved therapies, Omisirge® (omidubicel-onlv) and APHEXDA® (motixafortide). Omisirge® is a nicotinamide (NAM) modified allogeneic hematopoietic progenitor cell therapy that is potentially curative for patients with hematologic malignancies. APHEXDA® is a CXCR4 antagonist with long receptor occupancy indicated in combination with filgrastim to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
General Scope and Summary
The QA Junior associate for Manufacturing main role is to be responsible for Batch Records (BRSs) review, approval, batch release for shipment, batch release for infusion, final release for clinical and commercial batches and to perform release for other batches. This includes also communication with the QP that is a part of the batch release for commercial batches and clinical batches from phase III.
In addition, the QA Junior Associate provides support for quality aspects of the production department.
In case of a deviation, this function should immediately react according to the relevant SOPs.
The QA Junior associate will report to the QA Associate Director – E2E.
Roles and Responsibilities
- Ensure GMP compliance of Gamida Cell and CMO facilities to support all manufacturing activities
- Prepare, review and approve master documents related to Manufacturing (including Batch Records (BRSs), SOPs, test methods, validation protocols and reports)
- Review and approve all BRSs for all activities of the Production Department
- Release of all batches manufactured by Production Department
- Gather all raw data required for the release including relevant certificate of analysis.
- Support all Aseptic Process Simulation (APS) activities
- Participating in internal routine inspection being performed by QA
- Contribute to investigations, risk assessments, change controls, deviations, and CAPAs
- Prepare, review, and approve executed validation protocols and reports
- Support on site and virtual audit activities, to ensure ongoing compliance
Experience, Education and Specialized Knowledge and Skills
- Bachelor’s degree or higher in science-related field, or equivalent work experience (at least 3 years’ experience with GMP)
- English – good proficiency in reading, writing, and comprehension
- Excellent computer proficiency (MS Office – Word, Excel, Power Point and Outlook)
- Communication skills, team player with the ability to work under pressure and meet deadlines
- Ability to work both independently and as part of a team within a dynamic production environment
- Attention to details and ability to identify discrepancies or deviations in documentation
- High level of integrity, responsibility, and commitment to maintaining product quality and patient safety
- Advantage: Competent in the application of cGMP principles and change control
- Advantage: Proficient in root cause analysis and risk assessment methodologies
- Advantage: Knowledge of Quality Assurance requirements in the FDA and IMOH regions is required
Travel: None
Reports to: QA Associate Director – E2E
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