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Job Description:QA Coordinator, Cell Therapy and Cell Engineering Facility
Summary:
We are seeking a meticulous and proactive Quality Assurance Coordinator to join our team. This role entails managing vendor relationships, coordinating schedules, developing quality agreements, conducting audits, following up on testing results, assisting with CMC preparation, and ensuring that our operations comply with regulatory standards.
Role Overview:
- Vendor Relationship Management: Handle all external vendor interactions, including SOWs, contracts, SOPs, quotes, and budgets. Update relevant documents as necessary.
- Vendor Qualification: Conduct and document vendor qualifications, manage contract submissions, oversee the controlled stability of vectors, and assist in vendor audit activities.
- Quality Agreement Management: Manage and facilitate the review process for quality agreements.
- Sample Testing Coordination: Review sample testing and shipment requirements, prepare submission forms, schedule and coordinate shipments for external testing, ensuring compliance.
- Testing Results Follow-Up: Ensure timely and efficient follow-up on testing results.
- Smartsheet Maintenance: Maintain Smartsheet for external testing, ensuring it includes all required external submissions.
- Raw Material Qualification: Coordinate raw material qualifications and ensure all material COAs/COCs are sourced at the time of ordering and receipt.
- Procurement Info Management: Update and maintain procurement and qualification information presentation files for key reagents, such as plasmid, FBS, and human serum.
- CMC Preparation Support: Assist in CMC preparation, including project onboarding, discussions, email chains, and documentation.
- CMC Response Management: Maintain and organize responses related to CMC, including testing, holds, and other topics.
- Regulatory Compliance: Prepare and respond to FDA inquiries, ensuring compliance and timely communication.
- Product Test Record Review: Review product test records for completeness and accuracy.
- Quality Concerns Management: Raise quality concerns when appropriate and assist in planning, implementing, and following up on corrective actions.
- Change Requests and SOP Updates: Assist in change requests, SOP, and MPCR updates, ensuring they are housed in the Quality Plan (QP).
- Purchase Order Guidelines: Create and upload guidelines for purchase order management and invoice approvals.
Key Qualifications:
- 2-4 years of work experience. Experience in lean management is desired.
- Regulatory Knowledge: Familiarity with regulatory requirements and guidelines for quality assurance.
- CMC Experience: Experience in CMC preparation and responding to regulatory inquiries, particularly from the FDA.
- Vendor Management: Proven experience in managing and developing vendor relationships.
- SOP Development: Ability to develop and implement Standard Operating Procedures (SOPs).
- Raw Material Qualification: Experience with raw material qualification processes.
- Technical Proficiency: Proficiency in using project management tools like Smartsheet and document management systems like BOX.
Core Skills:
- Communication: Strong communication skills to interact confidently and professionally with internal and external collaborators.
- Organization: Excellent organizational skills to manage multiple tasks and projects efficiently.
- Analytical Skills: Strong analytical skills to ensure accuracy and thoroughness of documentation and records.
- Problem-Solving: Ability to independently resolve issues and questions.
- Flexibility: Adaptable to new projects and able to support various functional units.
- Prioritization: Capable of successfully prioritizing tasks and following through in a timely manner.
- Detail-Oriented: Meticulous attention to detail to ensure accuracy and thoroughness.
Additional Information:
- Location: 417 E 68th St, NYC
- Schedule: On site
- Reporting to the Core Director, Cell Therapy and Cell Engineering Facility
Compensation Range: 73,900-$114,400
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Closing:MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.
Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.
