Principal Analyst, QC Compliance, Operations
Are you ready to use your experience and expertise to make an impact on patients' lives? Astellas Gene Therapies is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you'd like to be a part of this important mission, please apply to join our team.
About Astellas Gene Therapies
Astellas Gene Therapies is developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for the newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: [Register to View] style="color: blue;">www.audentestx.com.
- Be BOLD (Find a Way)
- Care Deeply -- for our patients, each other and our work
- #GSD (Get Stuff Done)
What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.
We are looking for a self-motivated candidate to join the Operations Group within the Quality Control Department. The Senior Analyst/Principal Analyst, QC Compliance, Operations, who will report to the Manager, QC Operations, will be responsible for compliance of the laboratory operations to internal procedures and regulatory standards ensuring inspection and commercial readiness of the QC operations. Must have demonstrated track record of ability and initiative to work independently and in a collaborative team-oriented setting in line with the vision/mission of the core group. The position will be in our offices in South San Francisco, CA.
Areas of responsibility, include but are not limited to:
- The validation of computerized systems, qualification and maintenance of equipment, and management of quality records;
- All aspects of the role will require active management of the integrity of data.
- Improvement and optimization of laboratory operations including training program to provide a robust and scale-able process that is compliant and efficient will be an area responsibility
- Ensure data integrity principles are applied across the organization including identification of gaps and resolution.
- Ensure the performance and process of Quality Control to assure that product and process meet company and regulatory requirements
- Identify QC compliance gaps and improvements towards resolution for successful inspectional and audit outcomes.
- Participate and represent the QC organization in regulatory inspections and internal audits including interfacing with inspectors, as needed.
- Responsible the qualification and maintenance including scheduling of equipment to ensure laboratory operations are maintained with minimal interruptions to business needs.
- Responsible for the validation of computerized software or tools within Quality Control in accordance with industry standards, regulatory expectations, and data integrity while assuring business needs are met for the intended use.
- Manage the quality records (e.g. laboratory investigations, deviations, change controls, and CAPAs) for Quality Control ensuring on time closure, escalation of issues, and root-cause analysis to identify root cause and improvements.