Contract Principal Specialist, QA Validation

At Editas Medicine, we are pioneering the possible. Our mission and commitment is to translate the power and potential of the CRISPR/Cas12a and CRISPR/Cas9 genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world.  Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.  

Why Choose Editas?

At Editas Medicine, we’re a team of courageous problem solvers, harnessing the power and potential of CRISPR gene editing to transform the future of medicine. Driven by a shared purpose to serve people living with serious diseases, we succeed together through collaboration, mutual respect, and innovation. If you want to be part of a team where your voice is heard and respected, where you can operate at the forefront of gene editing, and push the boundaries of what’s possible in medicine, come join us and become an Editor!

Decoding The Role:

As a contractor within our Quality Assurance Validation team, you’ll be a vital contributor to our mission and our success. The Quality Assurance Validation (QAV) contractor will have deep expertise in benchtop equipment and computer systems commissioning and decommissioning. The ideal candidate should have experience with Veeva QMS, Blue Mountain Regulatory Asset Manager (BMRAM), and Kneat (or similar paperless validation solutions). In addition, they should have a proven track record with management of quality events such as Change Controls, CAPAs, and Deviations, coupled with strong written and verbal communication skills.

Characterizing Your Impact:

As the Principal Specialist, QA Validation, you will:

• Be able to serve as an SME for Quality Assurance in commissioning and decommissioning activities of benchtop equipment, ensuring compliance with applicable regulations and internal policies. Should have knowledge of validation life cycle for equipment. Should be able to resolve validation-related discrepancies during equipment qualification and validation activities
• Experience with Facility/utility qualification activities.
• Should have experience with Computer Systems Validation for systems like Veeva, LIMS, Learning Management Systems, SMS (Supply chain management system), software/firmware associated with equipment.
• 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.  Ideally, with experience using Veeva QMS for documentation control, deviation management, CAPA and change control processes.
• Familiarity with Blue Mountain RAM workflows including calibration and preventive maintenance and out of tolerance (OOT) workflows.
• Experience with Kneat (or similar validation software)
• 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.
• Have knowledge and ensure compliance with all relevant quality guidelines, including FDA, EMA, ICH, and other global regulatory requirements.
• Ability to support other Quality Assurance tasks as needed.

Requirements

The Ideal Transcript:

To thrive in this role, you’ll need:

• 8+ years of experience in Quality Assurance Validation within the biopharmaceutical industry.
• Should have prior experience in the validation field and development/ execution of validation deliverables
• Extensive experience with benchtop equipment commissioning and decommissioning processes.
• Extensive experience with Computer Systems Validation (CSV) and familiarity with GAMP 5 principles and applicability.
• Strong knowledge of data integrity principles and application in benchtop equipment usage; quality guidelines, including FDA, EMA, ICH, and other global regulatory requirements.

Fundamentals That Set You Apart

• Proficiency with Veeva QMS, Blue Mountain RAM, and Kneat or similar paperless validation systems.
• Familiarity with Quality Events: Change Controls, CAPAs, and Deviations.
• Excellent written and communication skills.
• Proven experience with a risk-based approach to validation and quality activities.

This role is critical for maintaining our compliance and quality standards in a fast-paced and dynamic environment. If you are a detail-oriented validation and QA expert with a passion for quality and continuous improvement, we encourage you to apply.