Genezen's Senior Quality Assurance Specialist
4 days ago
Genezen is a cutting-edge biotechnology company dedicated to revolutionizing the field of gene therapy. With a strong focus on scientific excellence and patient-centricity, we strive to accelerate the development of innovative treatments for patients worldwide.
Job SummaryWe are seeking an experienced Senior Quality Assurance Specialist to join our team in Fishers, Indiana or Lexington, Massachusetts. As a key member of our quality assurance department, you will play a critical role in ensuring the integrity of our manufacturing processes, products, and services.
Responsibilities- Lead Qualification and Procedures: Collaborate with the analytical development team to qualify reliable methods for QC testing, ensuring compliance with cGMP guidelines.
- Perform Laboratory Procedures: Conduct hands-on laboratory procedures related to viral vector production and characterization, evaluating new technologies for testing of cell and gene-based therapies.
- Maintain Lab Operations: Order, organize, and maintain lab reagent material stocks, assist with sample organization and testing, and manage outsource sample shipping and receiving.
- Document Processing Activities: Maintain cGMP documentation of processing activities, perform routine lab maintenance, and train new staff members in designated processes.
- Education: Bachelor's degree in Biology, Biochemistry, Molecular Biology, or a similar field.
- Experience: 3+ years of relevant industry experience in QC, R&D, product development, or operations.
- Skills: Excellent computer, verbal, and written communication skills; experience with laboratory techniques, including cell culture, cell-based assays, qPCR, ddPCR, flow cytometry, ELISA, and/or biostatistical analysis.
- Paid vacation days, amount based on tenure.
- Paid sick time.
- 9 observed holidays + 1 floating holiday + 1 volunteer day.
- 401(k) plan with company match up to 6% of salary, vested immediately.
- Share Appreciation Rights.
- Choice of several healthcare plans.
- FSA and HSA programs.
- Dental & vision care.
- Employer-paid basic term life/personal accident insurance.
- Voluntary disability, universal life/personal accident insurance.
- Accidental Death & Dismemberment (AD&D) Insurance.
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