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Quality Assurance Specialist I

Company: Vericel Corporation
Location: Cambridge
Posted on: November 22, 2021

Job Description:

If you start your application and need to come back to it, please click on the 'Forgot your password?' link to retrieve your profile information in order to get back into your application. Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Quality Assurance professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Manager, Quality Operations at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve. 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 and site requirements. Position Summary: This position is responsible for operational support, including batch record review, media disposition, label issuance and reconciliation, archiving and final product packaging/release to the courier. ESSENTIAL FUNCTIONS Core Responsibilities:

  • Responsible for batch record documentation and for final batch disposition
  • Support day to day operations, including: batch record and label issuance, archiving and verification
  • Review and approve product and process deviations.
  • Follow oral and written procedures for review and release of intermediate and final product.
  • Participate in audits to ensure compliance to cGMPs and Vericel requirements.
  • Identifies deficiencies and works with internal departments to remedy them. QUALIFICATIONS, EDUCATION AND EXPERIENCE 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 sound judgment in performing our jobs. Basic Qualifications:
      • High School Diploma plus 1 year of GMP experience Preferred Qualifications:
        • Strong written and verbal communication skills.
        • Strong organization and time management skills.
        • Proficient in MS Office suite.
        • Experience in a biotech, pharmaceutical or other regulated industry. WORKING CONDITIONS AND PHYSICAL DEMANDS
          • Ability to lift and transport up to 40 lbs.
          • Rotating holiday coverage.
          • Schedule: Tuesday-Saturday, 8:00am-4:30pm

Keywords: Vericel Corporation, Cambridge , Quality Assurance Specialist I, Other , Cambridge, Massachusetts

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