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 to support timely execution of validation projects
• Participate in change control assessments, risk assessments, and deviation investigations
• Support audits and regulatory inspections by providing validation documentation
• 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
• 7+ years of equivalent work experience in lieu of a degree
• Knowledge of 21 CFR, ICH, EU Regulations, GAMP 5, and risk-based validation
• Experience with Kneat strongly preferred

Preferred Qualifications

• Prior experience working in cell and gene therapy manufacturing
• Prior experience working with contract manufacturing

Benefits

• 6-12 month contract with possible extension