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CQV Specialist

Company: Katalyst Healthcares & Life Sciences
Location: Raritan
Posted on: March 20, 2023

Job Description:

Job Description :

  • Responsible for the day to day activities including execution, protocol management,
  • vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems, and processes in support of personalized cell therapy production according to cGMP requirements.
  • Work in a collaborative team setting with Quality, Manufacturing Operations, Facilities & Engineering Quality Control, Operations Technical Support, Supply Chain and Planning.

    Roles & Responsibilities :

    • Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant
    • Manages multiple and complex CQV projects, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks.
    • Supports and/or owns technical and quality investigations, CAPAs and corrections.
    • Develops and performs any required remediation efforts and associated CAPA plans.
    • Authors, owns 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.
    • Executes, owns, assesses, and participates in the creation, revision and review of change controls, SOPs, and other documentation.
    • Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews

      Education & Experience :

      • Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
      • Strong interpersonal and written/oral communication skills.
      • Ability to quickly process complex information and often make critical decisions with limited information.
      • Proficient in applying process excellence tools and methodologies.
      • Ability to independently be responsible for a portfolio of ongoing projects.
      • Ability to pay attention to details and follow the procedures.
      • The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
      • Good written and verbal communication skills are required.
      • Ability to summarize and present results, and experience with team-based collaborations is a requirement.
      • Ability to work with others in a team environment.
      • 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 identify/remediate gaps in processes or systems.
      • 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).
      • Experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance.
      • Demonstrated ability to work independently, drive effective communication, coordination, and collaboration across relevant cross functional groups to establish a strong, compliant CQV program to enable robust production, testing and release of product to patients.

Keywords: Katalyst Healthcares & Life Sciences, Trenton , CQV Specialist, Other , Raritan, New Jersey

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