Quality Assurance Validation

Company : Katalyst HealthCares & Life Sciences

Location : Boston, MA, 02109

Posted Date : 9 October 2025

Job Details

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.
uthor 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 5+ years validation and/or quality assurance experience. In lieu of degree, 7+ years of equivalent work experience is required.
Knowledge of 21 CFR, ICH, EU Regulations, GAMP 5, 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.
pplies 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.