QA Specialist II, Validation, Contractor

ElevateBio; Waltham (MA); On-site; USD 75,000 - 95,000; Full time

Job summary

ElevateBio seeks a QA Specialist II for a 6-month contract focusing on validation processes in a cGMP facility. The role includes QA oversight, SOP management, and requires a Bachelor’s degree with significant industry experience. If you're passionate about quality assurance and collaborative problem-solving in biotechnology, apply to join this transformative team.

Qualifications

• 5+ years validation and/or quality assurance experience.
• Knowledge of regulations and risk-based validation essential.
• Team player with effective communication skills.

Responsibilities

• Provide QA oversight of CQV activities.
• Perform review of CMMS records related to asset management.
• Author and review SOPs in Veeva.

Skills

Knowledge of 21 CFR

Knowledge of ICH

Risk-based validation

Collaborative problem solving

Effective listening

Education

Bachelor’s degree in a technical discipline

Tools

Veeva

Kneat

Job description

QA Specialist II, Validation, Contractor

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QA Specialist II, Validation, Contractor

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ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.

The Role

ElevateBio is looking for a contractor as a Specialist II to join their growing QA Validation group. This is expected to be a 6 month contract position. The role is expected to be onsite in Waltham 3-4 days per week.

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.
• Author and perform review of SOPs in Veeva.
  
  

Requirements

• Bachelor’s degree in a technical discipline with 5+ years validation and/or quality assurance experience. In lieu of degree, 7+ 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.
  
  

Why Join ElevateBio?

ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.

We aim to be the dominant engine inside the world’s greatest scientific advancements harnessing human cells and genes to alter disease.

Our Mission

To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.

Our Vision

We seek to be the world’s most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

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