Editas Medicine Senior QC Specialist in Cambridge, Massachusetts
Editas is seeking a Sr. Quality Control Specialist to join the Quality team and play a significant role in the support of our product pipeline. Reporting to the Director of Product Quality. this position will be responsible for review of release data from both internal and external testing.
This position will be responsible for the in a variety of Quality Control activities including, but not limited to data review, trending, and reporting.
Candidates must have hands-on experience and demonstrated organizational skills in a regulated analytical/QC environment.
Key Responsibilities & Accountabilities:
Review routine/non-routine data from in-process, final product, raw material, environmental monitoring samples in accordance with Standard Operating Procedure.
Responsible for protocol and report generation, as required.
Perform sample management such as receipt, inventory, tracking
Coordinate shipment of samples to contract testing laboratories, as required.
Trend data and compilate trend reports and ensure data reporting tools are up to date.
Complete documentation in accordance with current Good Manufacturing Practices (cGMP).
Update QC SOP’s to ensure compliance to appropriate regulations
Responsible for change controls, OOS and deviations related to QC Operations, including investigations, as required.
Work closely with internal and external QC teams to ensure data is completed and reviewed to support Editas timelines and goals.
Work in compliance with cGMP’s, effectively demonstrates an understanding of cGMP's and how it applies to specific responsibilities
Communicates inter-departmentally and with outside contacts to solve technical issues
Exercises sound judgment and decision making when problem solving
Revise Quality System procedures
Perform other duties, as assigned.
Knowledge, Skills & Capabilities:
Proven ability to work independently as well as to collaborate and communicate effectively and work effectively in a team-oriented environment.
Working knowledge of current Good Laboratory Practices (GLP – 21 CFR Part58), Good Manufacturing Practices (cGMP – 21 CFR Part 210/211), and Electronic Records; Electronic Signatures (21 CFR Part 11).
Proficiency in the use of Microsoft Office, PowerPoint, electronic document and Training systems.
Experience with management and implementation of e-Quality Systems.
Presentation development and performance skills is a preferred
Good verbal and written communication skills
Demonstrated ability to collaborate with both internal and external parties to achieve targeted objectives
Demonstrated organizational skills to managing multiple projects and priorities.
Education & Relevant Work Experience:
Bachelor’s degree in biology, chemistry or other life science and at least 5-8 years of relevant industry experience in Quality Control in a Pharmaceutical/Biotech GMP environment.
Authorization to work in the United States indefinitely without restriction or sponsorship