Compliance Specialist

7 days ago


Westborough, Massachusetts, United States Astellas Pharma Full time
Compliance Specialist Job Description

Astellas Pharma Inc. is a pharmaceutical company with a strong commitment to innovation and quality. We are seeking a highly skilled Compliance Specialist to join our team at the Astellas Institute for Regenerative Medicine (AIRM) in Westborough, MA.

Job Summary

The Compliance Specialist will play a critical role in ensuring the quality and integrity of our products and processes. This includes performing QA reviews, identifying and reporting documentation errors, and tracking metrics to support monthly reporting. The successful candidate will also assist with the Deviation and Corrective/Preventive Action (CAPA) programs, internal audits, and the development of new or revised standard operating procedures (SOPs).

Key Responsibilities
  • Perform QA reviews of executed manufacturing batch records, QC test records, raw material inspection records, and calibration records.
  • Identify and report documentation errors and deviations from SOP or specifications in a timely manner.
  • Track basic metrics on reviewed documents to support monthly reporting.
  • Assist with the Deviation and CAPA programs, including investigations and root cause analysis.
  • Participate in internal audits and assist with the development of new or revised SOPs.
Requirements
  • Bachelor's degree in Life Sciences, Engineering, or Chemistry, with 2-3 years of related Quality Assurance experience in GMP-regulated industry.
  • Working fluency in Microsoft Office productivity suite, including Excel and PowerPoint.
  • Demonstrated knowledge of cGMPs for biotechnology, cell therapy, and/or gene therapy.
  • Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions.
Preferred Qualifications
  • ASQ certifications (e.g., certified quality engineer, quality auditor, quality professional, etc.).
  • Specialized knowledge of industry-related niche topics, such as bar coding, cell culture, auditing techniques, QC methods, HEPA filtration science, etc.
  • Previous experience interacting with regulatory agencies, representing technical deliverables as a subject matter expert, audit hosting/support, etc.
Benefits
  • Medical, dental, and vision insurance.
  • Generous paid time off options, including vacation, sick time, and national holidays.
  • 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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