Quality Assurance Validation Contractor

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
• Maintain 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
• 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