QC Associate II, Raw Materials Specialist

4 weeks ago

Westborough, Massachusetts, United States Astellas Pharma Full time

Job Summary:

Astellas Pharma Inc. is seeking a highly motivated Quality Control Analyst II, Raw Materials to join our team at the Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

This role 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.

Key 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.
  • Perform 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.

Requirements:

  • B.S. degree in Biology/ or other life science related degree with 3 + years of relevant industry experience in a quality control role.
  • MS with 0-2 years of laboratory experience.
  • Knowledge of GMP, SOP's and quality control process.
  • Strong written and verbal communication skills.
  • Ability to work weekends while rare, may be required.
  • Understanding of quality operations with ability to troubleshoot and solve technical problems. Independently contribute to the development of new testing methods. Continues to take on more responsibility to provide content for various documents and reports. Increasing ability to execute protocols and summarize results with limited guidance.

Preferred Qualifications:

  • Experience with ICH, USP, EP and JP guidelines for test methods.
  • Experience with 21CFR Part 11 Compliance.
  • Good documentation, data organization, Detail oriented, and willingness to learn.
  • Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion.
  • Strong interpersonal skills, highly collaborative within a multi-disciplinary team and contributes to a supportive and positive work environment.
  • Models our core values- Be Bold, Care Deeply, getting stuff done- while promoting the team culture and compliance.

Benefits:

  • Medical, Dental and Vision Insurance
  • Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including 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

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