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Quality Systems Engineer

1 month ago

Westborough, United States Astellas Full time

Quality Systems Engineer

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.

AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.

Astellas is announcing a Quality Systems Engineer opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

The Quality Systems Engineer role participates in the development and execution of key compliance functions within the larger GMP Quality Assurance department. This position indirectly supports ongoing manufacture of biological clinical trial materials by providing timely and compliant support for quality systems including Change Control administration, Calibration / Validation review, MasterControl system administration and workflow development, inspection management and hosting, internal auditing, supplier management, site Quality Council, quality metrics generation, and site-level compliance deliverables.

Essential Job Responsibilities:

  • Assists with the management and administration of the GMP Change Control program. Assists users with navigating the change control decision tree and developing comprehensive change requests. Follows up on action items and assists with change request closure and effectiveness review.
  • Performs select technical review as needed, including review of calibration records, executed validation protocols, supplier audit responses and change notices, and other content as appropriate.
  • Assists with the generation of quality-facing monthly metrics for distribution to Technical Operations and Quality Assurance management, and for review by the Quality Council.
  • Assists with internal audit tracking and scheduling. Coordinates scheduling of lead auditors, co-auditors, and auditees. Tracks audit responses and commitments.
  • Assists with supplier management program, facilitates Raw Material Risk Assessments for new and changing materials, and helps maintain Supplier Audit schedule. May participate in supplier audits and / or tracking of supplier audit commitments.
  • Becomes a resource fluent in aseptic cell culture manufacturing and provides consultation on quality considerations related to aseptic biotechnology manufacturing.
  • Supplies management with relevant compliance insights; highlights and engages continuous improvement opportunities.
  • Performs other duties as assigned or special projects as needed.