Job Title

Kelly Science is seeking a Principal QA Validation Specialist for a growing company located in Cambridge, MA.** This position is a hybrid role which includes 2-3 days on-site** Pay: $80-90hourEmployment Type: 6+ month contractSummary:As the Principal QA Validation Specialist, you will be responsible for will be responsible for providing expertise in benchtop equipment and computer systems commissioning and decommissioning. You will also be responsible for other quality assurance matters as well.Job Duties Include:Serve as a Subject Matter Expert for Quality Assurance in commissioning and decommissioning activities of benchtop equipment.Ensure compliance with applicable regulations and internal policies.Resolve validation-related discrepancies during equipment qualification and validation activities.Ensure data integrity principles are incorporated into benchtop equipment operations, maintenance, and data capture processes at the time of qualification.Review and approve validation documentation.Support quality events, including Change Controls, CAPAs, and Deviations.Apply risk-based approaches to validation and quality assurance activities, ensuring prioritization of high-impact tasks.Collaborate with cross-functional teams, including Validation, R&D, Quality Control, and Manufacturing, to ensure quality assurance and validation deliverables are met.Qualifications:Bachelor's degree8+ years of experience in quality assurance validation within a biopharmaceutical environment.Extensive experience with benchtop equipment and commissioning and decommissioning processes, computer system validations (CSV), and managing quality events including Change Controls, CAPAs, and Deviations.Proficiency with Veeva QMS, Blue Mountain RAM and Kneat (or similar paperless validation systems)Possess a strong knowledge of validation life cycle for terested? Please apply today for immediate consideration!