At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.Together, we are leading the way towards a healthier and more equitable future.Position SummaryThe QA Document Control Senior Associate will be responsible for assisting in the management of Quality Assurance and other essential documents via the use of the company Electronic Document Management System (eDMS), Veeva Vault. This individual will prepare, route, format and track the documents received as per project guidelines in a timely manner. They will be responsible for housekeeping of the system and will perform system security reviews periodically. The ultimate responsibility will be to ensure regulatory inspection readiness.RESPONSIBILITIES:
Provide administrative support and training on Editas eDMS and Editas eQMS (Veeva Vault).
Support in creating documents and workflows within Veeva QualityDocs and assist in making enhancements to the system as per business needs.
Assist in writing and implementing SOPs and responsible for ensuring compliance with company SOPs.
Provide support in testing and validation activities during scheduled system maintenance releases.
Check format and conformance to company’s templates and policies. Ensure documents that fail quality content review are effectively remediated by internal/external representatives.
Maintain the document archival room. Assist in scanning, organizing, and archiving documents/records GxP regulations.
Recognize opportunities for documentation improvement and help implement new strategies.
Issue/Generate Logbooks and/or Batch Records for GMP related activities.
Provide training on e-systems to new employees.
Provide Administration Support for Editas eLMS (ComplianceWire).
Assist with day-to-day Document Control activities.
Perform other Quality System support activities as necessary
Ability to travel to other sites as required
Requirements
BS/BA Degree required in life sciences with 3 or more years industry experience
MS with one or more years industry experience
Working knowledge of current Good Manufacturing Practices (cGMP – 21 CFR Part 210/211), and Electronic Records; Electronic Signatures (21 CFR Part 11).
Proven ability to work independently as well as to collaborate and communicate effectively and work effectively in a team-oriented environment.
Proficiency in the use of Microsoft Office, PowerPoint, electronic document, and Training systems.
Experience with management and implementation of e-Quality Systems.
Experience with Veeva eDMS, Veeva eQMS and ComplianceWire eLMS is preferred.
Good verbal and written communication skills
Demonstrated organizational skills to managing multiple projects and priorities.
Ability to maintain a high level of accuracy and attention to detail in a fast-paced environment.
BenefitsBenefits Summary:Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.If you are a results-focused and collaborative professional with a passion for advancing transformative therapies, we invite you to apply. Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.Fostering Belonging. Fueling Innovation. Transforming Lives.
