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Urgent! Quality Assurance Validation Job Opening In Boston – Now Hiring Katalyst HealthCares & Life Sciences

Quality Assurance Validation



Job description


Roles & Responsibilities:

  • Provide QA oversight of CQV activities for the cGMP manufacturing facility and quality control laboratories.

  • Provide QA oversight for periodic review and requalification program.

  • Perform review of CMMS records related to asset management including asset release, database requests, and work orders.

  • Author and perform review of SOPs in Veeva.

  • Review and approve validation protocols and reports (IQ, OQ, PQ, CSV, process validation, cleaning validation).

  • Ensure compliance of validation activities with applicable GMP regulations, industry guidance, and internal SOPs.
  • Collaborate with cross-functional teams (Validation, QA, Engineering, Manufacturing, QC) to support timely execution of validation projects.

  • Participate in change control assessments, risk assessments, and deviation investigations related to validation.

  • Provide QA input during validation planning and execution phases.

  • Support audits and regulatory inspections by providing validation documentation and addressing QA-related inquiries.

  • Ensure data integrity and documentation accuracy in all validation records.

  • Requirements :
  • Bachelor's degree in a technical discipline with + years validation and/or quality assurance experience.

    In lieu of degree, + years of equivalent work experience is required.

  • Knowledge of CFR, ICH, EU Regulations, GAMP , risk-based validation.

  • Prior experience working in cell and gene therapy manufacturing preferred.

  • Prior experience working with contract manufacturing preferred.

  • Experience with Kneat strongly preferred.

  • Applies collaborative approach to problem solving and is experienced with risk-based decision making.

  • Team player who works well in large multi-disciplinary project groups by listening effectively and inviting open discussion.



  • Required Skill Profession

    Engineers



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      Unlock Your Quality Assurance Potential: Insight & Career Growth Guide


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