Responsibilities
- Provides dedicated QA support to client projects and client interactions & meetings; involved from inception of a client’s project until project closure
- Supports Clinical QA activities, including initial process development and non-clinical batch production
- Monitor day-to-day Quality Assurance activities in accordance with approved SOPs/Policies for cGxP integrated contract manufacturing facility
- Ability to troubleshoot, identify process pathways, and develop improvement strategies for site teams on projects/issues
- Understand advanced topics pertaining to cGMP
- Participate in regulatory inspections or customer audits as required
- Understand and articulate company business strategy, maintaining a broad view of the business and recognizing changes and trends
- Review executed batch records and logbooks efficiently to ensure compliance with cGMP per written procedures
- Compile lot genealogy and lot disposition packages, driving lot disposition activities to ensure timely product release
- Provide oversight to product status, including preparation of documents for shipping activities
- Oversee the quality tag-out system
- Actively participate in and approve deviation investigations, utilizing Root Cause Analysis tools for effective and timely closure
- Ensure correct implementation of CAPA based on deviations raised and ensure timely closure of CAPA
- Timely escalation of quality events on the floor based on knowledge of defined SOPs and policies
- Support changeover activities and QA on call
- Provide training to new members and manufacturing teams
- Provide quality oversight for operations document changes (e.g., MBRs, SOPs, forms, logbooks, etc.)
- Provide quality change request oversight for process and operation changes
- Detect non-compliance with cGMP and GDP requirements and provide guidance on GDP corrections
- Revise, review, and approve SOPs, protocols, reports, and records
- Perform any other tasks as assigned
Requirements
- Bachelor’s degree in a related field (e.g., Life Sciences, Engineering, Quality Assurance, etc.)
- 5-8 years of experience in quality management or quality assurance, preferably in a regulated industry (e.g., medical devices, pharmaceuticals, cell & gene therapy, etc.)
- Strong knowledge with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7)
- Knowledge and experience of the practical and theoretical requirement of quality management system in GMP facility
- Team player who can operate independently, with strong focus on safety, quality and timelines
- Excellent communication, organizational, and analytical skills in a fast-paced, dynamic environment
- Strong attention to detail and commitment to ensuring high standards of quality and compliance
- Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset
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What We Do
Cellares is revolutionizing cell therapy manufacturing. We are developing a one-of-a-kind solution, The Cell Shuttle, to overcome the challenges associated with manufacturing so these life-saving therapies are affordable and widely available to patients who can benefit. The clinical impact of cell therapy in treating cancer has been proven, but this therapeutic approach has several limitations, especially in manufacturing, leaving extremely sick patients waiting for treatment and desperate for hope. Since cell therapy is currently produced for a single patient at a time, it is expensive to manufacture, requiring significant time and resources, and is difficult to scale. Preclinical and clinical scientists, as well as commercial cell therapy manufacturers also lack the options to fully automate their manufacturing process quickly, safely, cost-effectively and at the scale they need. The Cell Shuttle is an automated and closed end-to-end manufacturing solution that is flexible and scalable, enabling customers to run exact processes specified for their cell therapy. Compared with the current manual manufacturing processes for cell therapy, the Cell Shuttle’s next-generation automated manufacturing solution has 10 times the scalability (meaning 10 times more patient doses can be produced simultaneously), enables a three-fold reduction in process failure rates and will reduce the per-patient manufacturing cost by up to 70 percent for most processes.
