Specialist I, QA Validation

ElevateBio • Waltham, MA

16h

About The Position

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently. The Role: ElevateBio is looking for a Specialist I to join their growing QA Validation Group, the ideal candidate is familiar with Commissioning and Qualification of Quality Control lab space, manufacturing suites, and associated equipment/instrumentation.

Requirements

• Bachelor’s degree in a technical discipline with 3+ years validation and/or quality assurance experience.
• In lieu of degree, 5+ years of equivalent work experience is required.
• Knowledge of 21 CFR, ICH, EU Regulations, GAMP 5, risk-based validation.
• 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.

Nice To Haves

• Prior experience working in cell and gene therapy manufacturing preferred.
• Prior experience working with contract manufacturing preferred.
• Experience with Kneat strongly preferred.

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.
• Provide QA oversight for quality events for validation and engineering operations (including deviations and related CAPAs).
• Provide feedback within a cross-functional team regarding inspection readiness activities.
• Author and perform review of SOPs in Veeva.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 251-500 employees