Department: QA

Office: Cambridge

Department Description:

The Quality Assurance department ensures that the site operates at a high level of compliance and ensures quality decisions are being made in accordance with Regulatory, corporate and site standards. 

Position Summary:

This position is responsible for the Quality Assurance Operational support regarding batch record review, issuing batch records, Biopsy Accessioning Packages, label issuance and reconciliation, verification, and final product packaging and release to the courier.

Core Responsibilities:

  • Support in maintaining and adhering to compliance requirements for established quality systems programs.
  • Support completion of analysis, identify issues and provide recommendations for compliance improvements. 
  • Participate in determining objectives of significant mid-scale projects or assignments. 
  • Demonstrate understanding of 21 CFR Part 11, 210, 211 and equivalent global regulations.
  • May interact with project teams and applicable research groups as they impact the quality operation.
  • Complete assignments with minimal supervision in a timely manner.
  • Support compliance requirements and time frames.
  • May interact with internal personnel on matters often requiring coordination between departments.
  • Effectively demonstrate an understanding of cGMPs and how it applies to specific responsibilities.
  • Follow accurate oral and written procedures for review and release of intermediate and final product.
  • Support day to day operations. Including: batch record issuance and review, label issuance, verification, archiving, and courier.
  • Participate in internal audits to ensure compliance to cGMPs and Vericel requirements.
  • Participate in TrackWise.
  • Participate in investigations.
  • Participate in the Metrics.
  • Participate in internal walk-through.
  • Provide input to the technical composition of operating documentation.
  • Effectively demonstrate an understanding of cGMPs and how it applies to specific responsibilities.
  • Work independently under general supervision and direction.
  • Work in compliance with cGMPs.
  • Practice safe work habits and adheres to Vericels safety procedures and guidelines.

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sou..nd judgment in performing our jobs.

 Basic Qualifications:

  • Bachelor’s degree or equivalent and 2+ years of related experience.
  • Strong written and verbal communication skills.
  • Must be able to work Tuesday - Saturday including rotating holiday coverage.

 Preferred Qualifications:

  • 1 year of experience in a CGMP lab environment.
  • Basic knowledge of GMP regulations.
  • Strong organization and time management skills.
  • Proficient in Outlook, MS Word, Excel and lab based data management systems.
  • Experience with microbiological testing or environmental monitoring.
  • Experience in a biotech, pharmaceutical or other regulated industry.

All qualified 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 Employer