CQV Specialist

Company:  Spark Life Solutions, Inc.
Location: Raritan
Closing Date: 02/11/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Roles & Responsibilities:
  • Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant contractors/vendors to complete tasks.
  • Manages multiple and complex CQV projects, provides status reports and coordinates with other departments or outside.
  • Supports CQV correction activities related to technical and quality investigations, CAPAs and corrections.
  • Authors and executes master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data integrity.
  • Support in the revision and review of CQV related SOPs, and other technical documentation as required.
  • Works in a collaborative team setting with Quality, Manufacturing Operations, Facilities & Maintenance.
Education & Experience:
  • Bachelors in science, Engineering or equivalent technical experience
  • CQV Cell Therapy and engineering experience required.
  • Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
  • Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
  • Ability to summarize and present results, and experience with team-based collaborations is a requirement.
  • Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
  • Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, CQV protocols.
  • Experience with TrackWise, CMMS and Maximo.
  • Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
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Spark Life Solutions, Inc.
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