Validation Coordinator
Vericel Corporation•Burlington, MA
•$61,000 - $67,000•Hybrid
About The Position
At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care). Position Summary: Responsible for the coordination of Calibration activities in a GMP biotech manufacturing facility.
Requirements
- Bachelor’s degree, or a high school diploma with a minimum of two (2) years of relevant experience in a cGMP environment within the biotech or pharmaceutical industry.
- Strong written and verbal communication skills.
- Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, etc.).
- Experience writing standard operating procedures.
- Strong customer service orientation.
Nice To Haves
- Experience working for a metrology organization in a cGMP environment.
- Able to work independently with minimal supervision in a team environment.
- Experience working within cross functional teams.
- Vendor management experience.
- Experience with Trackwise, Blue Mountain, MetTeams, Veeva Quality Docs.
Responsibilities
- Coordinate calibration events with external vendors.
- Coordinate calibration and certification activities with third-party vendors.
- Support and coordinate on-site contractors performing calibration activities.
- Maintain the calibration database.
- Review and approve calibration certificates.
- Maintain the MetTeams calibration system.
- Support and maintain the Equipment Management System (TrackWise and Blue Mountain RAM).
- Perform support activities such as scanning and filing to meet validation requirements.
- Create and revise departmental standard operating procedures (SOPs).
- Assist with internal and external audits.
- Adhere to all applicable internal and external policies and guidelines related to team activities and deliverables.
- Communicate routinely and effectively with management and team members.
- Contribute to internal project teams and cross-functional groups related to calibration activities.
- Support daily departmental activities as directed by management.
- Other duties as assigned.
Benefits
- Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
