Quality Assurance Specialist

1 month ago

Westborough, Massachusetts, United States Astellas Pharma Full time
Astellas Institute for Regenerative Medicine (AIRM) Job Opportunity

We are seeking a highly skilled Quality Assurance Compliance Specialist to join our team at Astellas Institute for Regenerative Medicine (AIRM) in Westborough, MA.

About the Role

This is an exciting opportunity to work in a dynamic and innovative environment, contributing to the development and commercialization of stem cell and regenerative medicine therapies. As a Quality Assurance Compliance Specialist, you will play a critical role in ensuring the quality and compliance of our manufacturing programs, working closely with cross-functional teams to achieve high-quality standards and value delivery for our patients.

Key Responsibilities
  • Perform QA review 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 Corrective / Preventive Action (CAPA) programs, aid investigations, and assume investigation leader status for select deviation investigations.
  • Help ensure that deviation records are clearly written, technically sound, and provide thorough root cause analysis and risk assessment.
  • May assist with the Internal Audit program for the organization, serving as an assistant auditor to help ensure all aspects of the GMP organization remain compliant with Astellas procedures and domestic / international GMP regulations.
  • Actively participate in continuous improvement opportunities to identify efficiencies and compliance improvements to benefit department operations or the organization at large.
  • Author (or assist in authoring) new or revised standard operating procedures (SOPs) for the QA department to satisfy new compliance requirements or improve work practices.
  • May assist senior QA staff in oversight of contract manufacturing organizations (CMO), monitoring information requests, reviewing CMO work, and following up on other compliance items.
Requirements
  • BS degree with 3+ years or MS with 0-2 years of laboratory experience.
  • Working fluency in the Microsoft Office productivity suite (including Excel and PowerPoint).
  • Experience with Electronic Document Management Systems.
  • Excellent oral and written communication skills.
  • Demonstrated knowledge of cGMPs.
  • Highly organized with a strong attention to detail.
  • Proven ability to manage both day-to-day operations, as well as project work in a fast-paced environment.
Preferred Qualifications
  • Demonstrated knowledge of cGMPs for biotechnology.
  • Working understanding of ICH Q7, Q8, Q9, Q10 and other international regulatory requirements.
  • Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions, and exercise sound Quality-by-Design principles.
  • Experience presenting these outcomes to management.
  • Specialized knowledge of any industry-related niche topics: 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.
  • ASQ certifications (e.g., certified quality engineer, quality auditor, quality professional, etc.).
Work Environment

This position is based in Westborough, MA and will require on-site work. The role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs. This is an on-site role working in a cGMP regulated manufacturing facility.

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.

Compensation: $74,300 – 99,000 (NOTE: Final salary could be more or less, commensurate with experience).

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

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