Astellas Pharma Quality Control Associate I in Marlborough, Massachusetts
The Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Marlborough, Massachusetts.
Astellas is announcing a Quality Control Associate I opportunity at their affiliate Astellas Institute of Regenerative Medicine (AIRM) in Marlborough, MA.
Performs all tasks necessary to support cell product manufacturing operations as it relates to Quality Control. Includes but is not limited to: Environmental monitoring and related material, cell inventory management, sample shipment to outsource testing labs and all related Documentation in accordance with GLP/GMP guidelines.
Essential Job Responsibilities:
- Environmental monitoring of cellular therapy production areas, processing and evaluation of environmental test samples.
- Coordinate with clinical production staff for daily EM test schedule and activities.
- Aseptic gowning for entry into controlled areas.
- Organization and completion of EM documentation and entering data into EM database.
- Perform in-process and final product analysis of clinical release which includes cell counts, viability analysis and subculture.
- Creates purchase order and performs inspection and release testing for raw materials used in QC microbiology lab.
- Assist with aseptic training and documentation of new employees for cleanroom.
- Prepares and stocks all shipping material required for samples to outsource testing labs.
- Process cell inventory requests with appropriate temperature sensitive methods.
- Coordinating and record keeping of cell product inventory for in-site and off-site storage.
- Based on business needs, availability and flexibility to work occasional weekends or rotating shifts.
- Bachelors in Life Science, Microbiology, Biochemistry or related discipline with 1 year
- relevant biotech or pharmaceutical industry experience.
- Associate degree with 2-4 years' experience in QC lab.
- Experience with FDA/cGMP compliance
- Cell culture experience/experience in medical device, microbiology testing procedures.
- Experience with liquid nitrogen and dry shippers preferable.
- Proficient in Microsoft word/Excel/Access
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Research and Development