Specialist I, QA Process Validation

The Role:

ElevateBio is looking for a Specialist I, QA Process Validation to join their growing Quality group. In this role the Specialist I will be responsible for managing cGMP compliance from a Quality Assurance prospective on technology transfer processes, Engineering manufacturing runs, process validation, process characterization, and PPQ. In addition, this position will support process and technology transfer risk assessments, technical reports, change controls, deviations, and CAPAs related to process validation activities. The candidate will contribute to team based collaborative environment promoting commitment to continuous improvement and achievement of goals.

Here’s What You’ll Do:

• Provide QA oversight of engineering run and process performance qualification protocols, reports, and discrepancies.
• Provide QA oversight in the development, review, and execution of technical protocols, reports, risk assessments, and discrepancy management.
• Provide QA oversight for Process Characterization activities.
• Change control assessment and approval to ensure proper impact assessment and sufficient testing to develop and maintain a validated state.
• Review and assist in investigating deviations and discrepancies related to process validation testing and technology transfer activities.
• Manage/complete Quality Risk Assessments (QRA) for Process Validation and Technology Transfer activities.

Requirements:

• Bachelor’s Degree in engineering, life sciences or related field with 3+ years of validation and/or quality experience
• Strong knowledge in process validation, process characterization, and technology transfer
• Prior experience with CMC a plus
• Strong knowledge of 21 CFR, ICH, EU regulations
• Prior experience in Cell and Gene Therapy manufacturing required.
• Strong technical writing skills and proficiency in various computer programs (Word, Excel, PowerPoint)
• Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based decisions.
• A team player, who listens effectively and invites response and discussion.
• A collaborator who communicates in an open, clear, complete, timely and consistent manner.