Quality Assurance Specialist, I

Job Description

Job Description

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

This position is responsible for conducting day-to-day activities. This includes, but not limited to batch record review, media disposition, label issuance, archiving and final product packaging and release activities. The individual must be able to gown into classified manufacturing ISO 7 clean room areas, to conduct inspection of final product.

Schedule: This position is primarily onsite in our new Burlington, MA office and follows either a Tuesday–Saturday or Sunday–Thursday schedule. During our transition to the new facility, some workdays will be spent at our Cambridge office.

During your first month, you will complete training Monday through Friday onsite both locations. After training is complete, you will transition to your assigned schedule (Tuesday–Saturday or Sunday–Thursday).

Responsibilities:

• Perform, as well as ensure that the review of batch records and release of intermediates is performed within required timeframes outlined in SOPs.
• Responsible for the packaging and final batch disposition.
• Responsible for inspection of final product within an ISO 7 cleanroom.
• Support day to day operations, including batch record review, label issuance, archiving and verification with supervision oversight and in a timely manner.
• Follow oral and written procedures for review and release of intermediate and final product.
• Support projects as a QA resource.
• Identifies deficiencies and works with cross functional departments to remedy them.
• Identifies issues and provides recommendations for process improvements within the department.
• Revise Standard Operating Procedures.
• Other duties as assigned.

Basic Qualifications:

• High School degree/GED with 2 years of relevant pharmaceutical/biotech experience or Bachelors plus 0-1 years of relevant pharmaceutical/biotech experience.
• Basic working knowledge of GMP regulations.

Preferred Qualifications:

• Strong written and verbal communication skills.
• Strong organization and time management skills.
• Proficient in MS Word and Excel
• Experience with electronic batch records, ERP systems and Quality Management Systems (Examples: TrackWise and Veeva).

WORKING CONDITIONS AND PHYSICAL DEMANDS

• Ability to lift and transport up to 30 lbs.
• Must be able to work one weekend day.
• Must be able to support rotating holiday coverage.
• Must be able to gown into classified manufacturing ISO 7 clean room areas, to conduct inspection of final product.
• Must be able to gown into CNC areas.

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 $28.85 to $34 per hour.

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.