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Quality Systems Engineer
2 months ago
Astellas Pharma is seeking a highly skilled Quality Systems Engineer to join our team at the Astellas Institute for Regenerative Medicine (AIRM) in Westborough, MA. As a Quality Systems Engineer, you will play a critical role in ensuring the development and execution of key compliance functions within the GMP Quality Assurance department.
Key Responsibilities- Change Control Administration: Assist with the management and administration of the GMP Change Control program, including navigating the change control decision tree and developing comprehensive change requests.
- Technical Review: Perform select technical review as needed, including review of calibration records, executed validation protocols, supplier audit responses, and change notices.
- Quality Metrics Generation: Assist with the generation of quality-facing monthly metrics for distribution to Technical Operations and Quality Assurance management.
- Internal Audit Tracking: Assist with internal audit tracking and scheduling, including coordinating scheduling of lead auditors, co-auditors, and auditees.
- Supplier Management: Assist with the supplier management program, including facilitating Raw Material Risk Assessments for new and changing materials.
- Quality Considerations: Provide consultation on quality considerations related to aseptic biotechnology manufacturing.
- Compliance Insights: Supply management with relevant compliance insights and highlight continuous improvement opportunities.
- Education: BA/BS or equivalent with typically 2+ years relevant experience or typically 1+ years with Master's degree.
- Experience: In lieu of a Life Sciences degree, consideration will be given to candidates with minimum of 6+ years of relevant industry experience in biotechnological and/or pharmaceutical quality assurance and/or quality engineering.
- Compliance Regulations: Fluency in major compliance regulations and consensus standards, including 21CFR §11, §210, §211, §1271; EudraLex Volume IV (including ATMPs), ICH Q9, Q10, etc.
- Technical Skills: Strong proficiency in MS Word, Excel, PowerPoint, to include basic formulas, and creation/formatting of charts and data tables.
- MasterControl Experience: Experience with the MasterControl electronic Quality Management System.
- Supplier and Internal Audits: Experience with supplier and/or internal audits.
- Cell Culture Manufacturing: Working knowledge of cell culture manufacturing platforms.
- Communication Skills: Comfort presenting data, facilitating meetings with senior stakeholders, and maintaining minutes of key decisions and outcomes.
- Location: This position is based in Westborough, MA and will require on-site work.
- Medical, Dental, and Vision Insurance
- Generous Paid Time Off options
- 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
