Editas Medicine QA Specialist/Sr. QA Specialist, Quality Assurance Operations in Boulder, Colorado
Location – Boulder, CO or Cambridge, MA; What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) 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 many diseases. We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.
Editas is seeking a highly motivated and experienced quality professional to manage the quality activities at contract manufacturing organizations (CMOs) and to serve as the Quality Lead for external partnerships. This position will be responsible for managing all activities associated with product disposition, including coordination of contract testing organization (CTO) data review with the Editas QC department. The ideal candidate will have experience in the Biopharmaceutical industry.
Responsibilities will include:
Quality Assurance Lead for external collaborations to provide quality system expertise and help identify solutions and ensure compliance to GMP
Build on relationships within our CMOs ensuring issues impacting quality product quality are tracked and resolved in a timely manner.
Support External Quality partnerships as required in the initiation and follow up of deviations, CAPAs, and change controls.
Responsible for compliance with documentation management system (quality agreements, CMO performance evaluations, master batch records, analytical data, etc.).
Author, review and approve GMP documentation (SOPs, batch records, protocols, technical reports, test methods, protocols, specifications, and summary reports to support GMP manufacturing).
Support projects, and global processes alignment (internal and external) as well as continuous improvement and initiatives.
Review executed batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, and that all limits and specifications have been met.
Review and approve deviations, change controls and CAPAs for appropriateness, completeness and to meet internal procedures and regulatory expectations.
Work collaboratively with cross functional teams, partners, and vendors to gather background knowledge needed to complete assignments.
Develop and maintain Quality Agreements with contract manufacturers, suppliers, and laboratories
Independently coordinates complex investigations in cross-functional areas.
Anticipate issues and escalate to appropriate management attention immediately.
Exercises judgment in resolving moderate to complex quality issues.
Plan and execute work independently and consult with supervisor as needed.
Supports the organization in maintaining inspection readiness.
Review and approve validation protocols and reports to ensure compliance
Review analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans
Support generation of metrics for Management Review
Review stability protocols and reports
Conduct internal and external audits as required, track progress, and trend results
Occasional travel will be required
A Bachelor’s or Master’s degree in biology, chemistry or other life science and at least 5-8 years of relevant industry experience in Quality Assurance in a Pharmaceutical/Biotech GMP environment
A solid understanding of applicable regulations and guidelines pertaining to pharmaceutical product development. manufacturing, testing and clinical operations
Experience with GMP’s in a working manufacturing environment strongly preferred
A working knowledge of GMP requirements for Clinical Trial Material in both the US and EU including sterile manufacturing strongly preferred
Certified Quality Auditor (CQA) would be a plus
Investigational skills including Root Cause Analysis and Product Impact Assessments
Ability to manage multiple projects with minimal oversight in and evolving environment
Strong communicator and collaborator who possesses a flexible approach to problem solving and ability to apply risk-based decision making