What are the responsibilities and job description for the Validation Coordinator position at Vericel Corporation?
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.
Schedule: This position is onsite Monday - Friday in our new Burlington, MA office, but will be required to spend some days in our Cambridge office as we transition to our new facility
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.
Basic Qualifications:
- 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.
Preferred Qualifications:
- 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.
Working Conditions & Physical Demands:
- May require working in a clean room manufacturing environment including gowning.
- Must be able lift, push or pull up to 40 lbs.
- Must be willing to work overtime as required to meet department demands.
Why Vericel?
- Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
- Career Growth: Be a part of a growing organization with opportunities to expand your impact
- Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives.
The hourly wage range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $61,000 to $67,000 annually.
The actual salary offered will be determined based on factors such as the candidate’s qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above.
In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited.
EEO Statement
All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.
Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.
Salary : $61,000 - $67,000