Specialist I, QA Validation

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.

Here’s What You’ll Do:

• 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.

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.

• 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.

The budgeted range for this position is $43.27- $57.69. This range is a good faith estimate of the expected hourly range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.