QC Associate II, Raw Materials
Astellas

Astellas Institute for Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma Inc 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.

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 Massachusetts.

Astellas is announcing a QC Associate II, Raw Materials opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

Performs all tasks necessary for the support of GMP operations as it relates to Quality Control Raw Material (QCRM) program/department. This position performs release testing of raw materials used in the manufacture of AIRM cell therapy products in accordance with GDP/GMP guidelines.

Essential Job Responsibilities:

• Perform routine release testing of Raw Materials, such as compendial analysis per the USP, PhEur, JP or ACS monographs and general chapters in support of manufacturing, based on cGMP's and internal procedures. Testing includes, but is not limited to: pH, Osmolality, FTIR, Wet Chemistry and gas testing.
• Perform(s) validation/verification of analytical methods used in RM testing.
• Provide support and oversight of laboratory equipment, computer systems and PM/calibration program to ensure on-time testing completion.
• Perform author, review, and approve data, SOPs, qualification plans, specifications and technical reports as needed to ensure compliance with Good Manufacturing Practices (GMP).
• Support the shipment of samples to approved contract laboratories for testing.
• Maintain adequate inventory of supplies needed for all raw material sampling and testing.
• Collaborate with Manufacturing, Supply Chain and Quality Assurance to ensure an uninterrupted supply of raw materials for use in Manufacturing.
• Ensure data integrity of all generated quality control data from QCRM laboratory function.
• Review raw data and results from contract laboratories for raw materials testing.
• Ensures all tasks are performed in a manner consistent with safety standards.
• Participate in audits (internal / external) where necessary (prep, support, interactions) related to QC processes and RM program.

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