What are the responsibilities and job description for the Quality Analyst - Cell Therapy position at Global Technical Talent, an Inc. 5000 Company?
The details for this position are as follows:
Job Code: AZNJP00032303
Job Title: Quality Analyst - Cell Therapy
Location: Tarzana, CA 91356 (Hybrid - 2 Days Work from Home) - (Waltham but will be going to Kendal Square once it opens in October)
Duration: 12 months - extension and/or FTE conversion possible based on business needs and performance.
Pay Rate: $40.00/HR
Working Hours: Thursday - Sunday and Saturday - Wednesday
MUST WORK SATURDAY AND SUNDAY
Shift: open to 6:30 am or 8 am - they are open to 4X10 or 5X8
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Job Description:
The client is seeking an energetic and experienced individual with a cell therapy quality control background to join our Quality Control (QC) team. The successful candidate will contribute to the advancement of our product pipeline by performing QC analytical method qualification, executing lot release testing, sample management, and other assigned tasks. This position is essential for ensuring that the laboratory meets the high standards required for CGMP Quality Control Operations.
Essential Responsibilities:
- Perform CGMP release and stability testing (e.g., flow cytometry, ELISA, cell-based cytotoxicity, qPCR/dPCR) for cell therapy products and in-process samples.
- Receive, verify, label, store, and track samples, controls, and reagents to ensure traceability and timely transfer to testing laboratories, using paper and electronic systems and operating temperature-controlled units.
- Author and/or review analytical test results and technical documents, including analytical method qualification protocols and reports, and standard operating procedures (SOPs).
- Document activities, record observations, and complete all paperwork in accordance with CGMPs, SOPs, and protocols.
- Execute protocol-driven method qualification, verification, and validation, and support analytical technology transfer and method lifecycle management activities.
- Escalate and document invalid, OOS/OOT results; support deviations, CAPAs, and change controls; and contribute to investigations as needed.
- Follow Safety, Health, and Environmental procedures, maintain a safe and organized laboratory environment, and use appropriate PPE and aseptic/biocontainment practices.
- Perform other duties as assigned.
Qualifications:
- Bachelor's degree preferably in Biology or equivalent with 1-2 years of relevant CGMP laboratory experience; OR associate’s degree preferably in Biology or equivalent with 2-3 years of relevant CGMP laboratory experience
- The ideal candidate will possess excellent attention to detail, strong communication skills, and the ability to analyse raw data effectively.
- Experience with sample receipt, storage, and transfer.
- 1-2 years executing routine and non-routine analysis for CGMP lot release and stability testing using techniques including but not limited to cell culture, flow cytometry, and cell-based methods, PCR (dPCR, qPCR), Immunoassays (ELISA), etc.
- Familiar with basic computer applications such as Microsoft Outlook, Word, and Excel
- Experience operating and maintaining Temperature-Controlled Storage Units.
- Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced, dynamic team setting.
Preferred Qualifications:
- Experience in Cell or Gene Therapy.
- Well-versed in various analytical techniques, including flow cytometry, qPCR, dPCR, cell-based potency, and/or ELISA experience.
Salary : $40