Contract Senior QA Specialist, Quality Systems (3-6 month)

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 Systems group you will play an integral role in supporting day to day activities within document control, training and our Quality Management System, as outlined in the below responsibilities. This is a 3-6 month contract that will report to the Senior Manager, Quality Systems in our Quality organization.

Characterizing Your Impact:

As the Senior QA Specialist, you will:

Documentation:

• Format new and revised documents submitted for approval.
• Coordinate and manage the documentation program, including serving as documentation control reviewer/ approver and performing system administration for documentation management system.
• Facilitate the creation, revision, distribution, and issuance of controlled documentation (master batch records, logbooks, protocols, etc.).
• Oversee the periodic review process of controlled documents and related content.
• Support the archival of physical and electronic records.
• Author and approve standard operating procedures to support improvement and periodic review.

Training and QMS:

• Assist in managing the training program, including training assessments and assignments.
• Support the maintenance and updates of training curricula and the electronic training system.
• Perform training compliance periodic metric analysis and reporting to end users and senior management.
• Perform periodic quality system assessments.
• Other duties as assigned, i.e., providing support to other quality groups as needed.

Requirements

The Ideal Transcript:

To thrive in this role, you’ll need:

• Bachelor of Science (BS) degree in Science and Engineering.
• A minimum of five (5) years prior experience, as a Quality professional in the biopharmaceutical industry.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

Fundamentals That Set You Apart

• Proficient in Microsoft Office applications (Word, Excel, PowerPoint) and pharmaceutical GxP
• digital solutions; experience with Veeva QualityDocs and Veeva QMS is a plus.
• Strong knowledge of Quality Systems, Quality Assurance, and Quality Control, with solid
• understanding of global GMP and cGMP regulations.
• Excellent verbal and written communication skills, including technical writing.
• Must be able to work on multiple assignments in a collaborative and dynamic environment,
• demonstrating strong organizational, prioritization, and time management skills.
• Proven ability to work independently and effectively

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.