Astellas is announcing a QC Associate II, Raw Materials opportunity at their Astellas Institute of 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.

Qualifications:

Required:

• Education: BS degree in biotechnology or related field with 3+ years or MS in biotechnology or related field with 0-2 years with Quality Control experience in a pharmaceutical or biotech industry environment.

• Knowledge of GMP, SOP’s and quality control process

• Proficient in MS Word, Excel, Power Point and other applications.

• Strong written and verbal communication skills.

• While most of the schedule will be during a standard work-week, there will be occasional weekend work required.

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation, Sick time, national holidays, two Heritage Days, and Summer and Winter Breaks

• 401(k) match and annual company contribution

• Company paid life insurance

• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

• Long Term Incentive Plan for eligible positions

• Referral bonus program

Category GMP Technical Operations

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans