QC Associate II, Raw Materials at Astellas in Westborough, Massachusetts

Job Description:

QC Analyst II, Raw Materials

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

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 Analyst II, Raw Materials opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

Astellas, Westborough is seeking a highly motivated individual with strong organizational skills to join us as a QC Analyst II, Raw Materials. This position provides Quality Control compliance and release testing of raw materials used in the manufacture of Astellas 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 and review of data, SOPs, qualification plans, specifications and technical reports as needed to ensure compliance with Good Manufacturing Practices (GMP).


• Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations, Change Requests and CAPAs related to analytical procedures.


• Support the shipment of samples to approved contract laboratories for testing.


• Maintain adequate inventory of supplies needed for all raw material sampling and testing.


• 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.


• Perform QC lab duties and technical projects as required.

Quantitative Dimensions:

The QC Analyst II, Raw Materials routinely interact with Manufacturing, Materials Management and Quality Assurance. Will contribute to the development of QC departmental processes.

Organizational Context:

The QC Analyst II, Raw Materials will typically report to the QC Manager, Raw Materials or Next level line manager. This role is expected to model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas organization.