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WorkatHome-JobBoard ยท 2 days ago
QA Coordinator, Cell Therapy & Engineering
New York, NY
Full-time
Onsite
Mid Level
$74K/yr - $114K/yr
2+ years exp
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Responsibilities
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.
Qualification
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Required
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.
Company
WorkatHome-JobBoard
WorkAtHome-JobBoard is the leading job search site specializing in the best remote, part-time, freelance, and flexible jobs available.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase
