Regulatory Compliance Specialist for Raw Materials

6 days ago


Westborough, Massachusetts, United States Astellas Pharma Full time

Astellas Pharma Inc., a global pharmaceutical company, is seeking a highly motivated and detail-oriented Regulatory Compliance Specialist to join our team in Westborough, MA. As part of our Astellas Institute for Regenerative Medicine (AIRM), you will be responsible for ensuring the quality and compliance of raw materials used in the manufacture of cell therapy products.

This role provides a unique opportunity to work in a fast-paced environment, collaborating with cross-functional teams to develop innovative therapies for patients worldwide. With a focus on Good Manufacturing Practices (GMP) and regulatory compliance, you will play a critical role in maintaining the highest standards of quality and integrity in our operations.

Key Responsibilities:

  • Perform routine release testing of raw materials, including compendial analysis and general chapters, in accordance with cGMPs and internal procedures.
  • Validate and verify analytical methods used in raw material testing.
  • Provide support and oversight of laboratory equipment, computer systems, and PM/calibration programs to ensure timely testing completion.
  • Author and review data, SOPs, qualification plans, specifications, and technical reports to ensure compliance with GMP regulations.
  • Conduct investigations regarding out-of-specification (OOS) results 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.
  • E nsure data integrity of all generated quality control data from QCRM laboratory functions.
  • Review raw data and results from contract laboratories for raw materials testing.
  • E nsure 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:

  • Bachelor's degree in Biology or other life science-related field with 3+ years of relevant industry experience in a quality control role.
  • Masters' degree with 0-2 years of laboratory experience may also be considered.
  • Knowledge of GMP, SOPs, and quality control processes.
  • 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.

Preferred Qualifications:

  • Experience with ICH, USP, EP, and JP guidelines for test methods.
  • Experience with 21 CFR 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.

Salary Range: $80,000 - $110,000 per annum, depending on qualifications and experience.

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.



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