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GMP Quality Assurance Engineer

2 months ago

Westborough, Massachusetts, United States Astellas Pharma, Inc. Full time
Job OverviewPosition Summary

GMP Quality Assurance Engineer

Are you interested in joining a diverse team dedicated to creating groundbreaking therapies for patients? At Astellas, we are committed to developing and delivering innovative and effective medications to healthcare providers and patients alike. If you aspire to contribute to this impactful mission, Astellas is the right place for you.

Astellas Pharma Inc. operates globally in over 70 countries, focusing on transforming innovative scientific research into medical solutions that provide value and hope to patients and their families. Our commitment to addressing unmet medical needs while conducting our business with integrity and ethics allows us to enhance global health. For more information about Astellas, please visit our website.

Astellas Institute for Regenerative Medicine (AIRM), a wholly owned subsidiary of Astellas Pharma Inc., is dedicated to the advancement and commercialization of stem cell and regenerative medicine therapies. As a research-driven global pharmaceutical entity, Astellas aims to improve health worldwide through the provision of innovative and dependable pharmaceutical products.

AIRM boasts a top-tier research and development team, actively pursuing a variety of disease indications, including macular degeneration (currently in clinical trials) and other ocular conditions, as well as vascular and autoimmune diseases. AIRM's intellectual property portfolio encompasses pluripotent stem cell platforms, including both embryonic and induced pluripotent stem cells, alongside other cell-based therapy research initiatives. AIRM is headquartered in Massachusetts.

Astellas is currently seeking a GMP Quality Assurance Engineer to join their team at the Astellas Institute for Regenerative Medicine (AIRM) location.

Key Responsibilities:
  • Support the management and administration of the GMP Change Control program, assisting users in navigating the change control process and developing comprehensive change requests. Follow up on action items and assist with the closure and effectiveness review of change requests.
  • Conduct technical reviews as necessary, including evaluation of calibration records, executed validation protocols, supplier audit responses, and change notices.
  • Assist in generating quality-facing monthly metrics for distribution to Technical Operations and Quality Assurance management, and for review by the Quality Council.
  • Coordinate internal audit tracking and scheduling, including scheduling lead auditors, co-auditors, and auditees. Monitor audit responses and commitments.
  • Facilitate the supplier management program, conducting Raw Material Risk Assessments for new and changing materials, and maintaining the Supplier Audit schedule. May participate in supplier audits and track supplier audit commitments.
  • Become a knowledgeable resource in aseptic cell culture manufacturing, providing consultation on quality considerations related to aseptic biotechnology manufacturing.
  • Provide management with relevant compliance insights and highlight continuous improvement opportunities.
  • Perform additional duties as assigned or participate in special projects as needed.
Qualifications:

Required:
  • Bachelor's degree or equivalent with typically 2+ years of relevant experience, or typically 1+ years with a Master's degree.
  • In lieu of a Life Sciences degree, candidates with a minimum of 6+ years of relevant industry experience in biotechnological and/or pharmaceutical quality assurance and/or quality engineering will be considered.
  • Proficiency in major elements of the job description, with direct experience in at least one major area.
  • Familiarity with key compliance regulations and consensus standards, including 21CFR §11, §210, §211, §1271; EudraLex Volume IV (including ATMPs), ICH Q9, Q10, etc.
  • Strong skills in MS Word, Excel, and PowerPoint, including basic formulas and the creation/formatting of charts and data tables.
Preferred:
  • Experience with the MasterControl electronic Quality Management System.
  • Experience with supplier and/or internal audits.
  • Working knowledge of cell culture manufacturing platforms.
  • Comfort in presenting data, facilitating meetings with senior stakeholders, and maintaining minutes of key decisions and outcomes.
  • Experience in environments subject to regulatory audits.
Working Conditions:
  • This position requires on-site work.
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.