QC Specialist II

How you’ll make an impact:

As a QC Specialist II, you will support commercial-level GMP testing laboratories for instrument and equipment maintenance. This includes scheduling, performance, and documentation of routine maintenance in the QC Lab. They will support the instrument/equipment lifecycle process (e.g., asset induction, qualification, requalification, maintenance, and decommissioning) and continuous improvement of GMP systems to ensure a compliant Quality Control lab. 

About the team:

Our Quality Control team interfaces with vendors, Quality Assurance, Facilities and IT, and other cross-functional teams, as required. They will have an awareness of cGMP's good documentation practices and attention to detail for their work and others. This position is onsite for the Cambridge, MA office.

How you’ll spend your time:

• Working knowledge of existing controls (data integrity and control, cGMP documentation, laboratory audits, audit trail reviews, etc.) to support review/execution.
• Support the instrument/equipment lifecycle process (e.g., asset induction, qualification, requalification, maintenance, and decommissioning)
• Author Standard Operating Procedures, Forms, Work Instructions, qualification protocols, and technical reports.
• Own Quality Events such as change controls, deviations, investigations, CAPAs, effectiveness checks, and proactive initiatives.
• Execute internal validation/qualification documentation.
• Proactively maintain the lab for inspection readiness to ensure compliance by identifying and executing process improvements.
• Provide guidance and training to junior analysts and cross functional teams, as needed.
• Collaborate cross-functionally with site teams (Facilities, Quality Assurance Validation, Computer System Validation, Laboratory Information Technology, QA Document Control, Quality Control Testing, External Vendors, etc.) to mitigate workflow disruptions through effective communication.

Who you are and what you’ve accomplished:

• Associates with 2-5 years in a biotechnology discipline and 1+ years of experience in a cGMP/GxP environment is preferred
• Superb organizational, analytical, and communications skills and “do-what-it-takes” attitude
• A passion for addressing the critical unmet medical needs of patients • Self-directed individual who can work with limited direction in a fast- paced, goal-oriented environment