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Quality Systems Engineer

2 months ago


Westborough, Massachusetts, United States Astellas Pharma Full time
About the Role

Astellas Pharma is seeking a Quality Systems Engineer to join our team at the Astellas Institute for Regenerative Medicine (AIRM) in Westborough, MA.

Job Summary

The Quality Systems Engineer will participate in the development and execution of key compliance functions within the GMP Quality Assurance department. This role will provide timely and compliant support for quality systems, including Change Control administration, Calibration/Validation review, MasterControl system administration, and workflow development.

Key Responsibilities
  • Assist with the management and administration of the GMP Change Control program.
  • Perform select technical review, including review of calibration records, executed validation protocols, supplier audit responses, and change notices.
  • Assist with the generation of quality-facing monthly metrics for distribution to Technical Operations and Quality Assurance management.
  • Assist with internal audit tracking and scheduling, including coordination of lead auditors, co-auditors, and auditees.
  • Assist with supplier management program, including facilitation of Raw Material Risk Assessments for new and changing materials.
Requirements
  • BA/BS or equivalent with typically 2+ years relevant experience or typically 1+ years with Master's degree.
  • Fluency with major compliance regulations and consensus standards, including 21CFR §11, §210, §211, §1271; EudraLex Volume IV (including ATMPs), ICH Q9, Q10, etc.
  • Strong proficiency in MS Word, Excel, PowerPoint, including basic formulas and creation/formatting of charts and data tables.
Preferred Qualifications
  • Experience with the MasterControl electronic Quality Management System.
  • Experience with supplier and/or internal audits.
  • Working knowledge of cell culture manufacturing platforms.
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.