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QC Analyst II Cell Culture

Company: Vericel Corporation
Location: Cambridge
Posted on: November 23, 2022

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. Quality Control (QC) is responsible for incoming inspection of components and raw materials, plus quality testing (e.g. analytical, microbiological) of intermediate, stability and final product samples to demonstrate that all products manufactured meet standards required for current Good Manufacturing Practices (cGMP) operations. Various techniques (e.g. assay transfers, validation and qualification of new instrumentation) are utilized within the Quality Control Laboratory to ensure cGMP compliance. Position Summary: Responsible for performing routine and complex testing of in-process samples and final products in accordance with SOPs for product release and validation. ESSENTIAL FUNCTIONS Core Responsibilities:

  • Perform maintenance on complex laboratory equipment.
  • Participate in training of less experienced staff.
  • Participate in transfer methods from support groups to the QC laboratory.
  • May perform finished product review and lot release.
  • Perform cell culture maintenance and assays
  • Communicate inter-departmentally and with outside contacts to solve technical issues.
  • Exercise sound judgment and decision making when problem solving.
  • Revise standard operating procedures as needed.
  • Perform deviation and lab investigations as needed.
  • Other duties as assigned. 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:
      • Bachelor's degree or equivalent and 3+ years of experience or MS with 0-1+ years' experience in a lab setting.
      • 2+ years of experience in cell culture
      • 1+ years of experience in flow cytometry and/or molecular biology Preferred Qualifications:
        • 1+ years of experience in a cGMP lab environment.
        • Proficient in Outlook, MS Word, Excel and lab-based data management systems.
        • Experience with microbiological testing, biological assays, or environmental monitoring.
        • Experience in a biotech, pharmaceutical or other regulated industry.
        • Excellent communication skills, verbal and non-verbal desired.
        • Excellent technical writing and investigational skills. WORKING CONDITIONS AND PHYSICAL DEMANDS
          • Ability to lift 40 lbs.
          • Rotating holiday coverage.
          • Rotating off-shift alarm coverage. May carry a company issued cell phone for rotating off-shift alarm coverage.
          • May be required to work in classified and controlled areas such as clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.

Keywords: Vericel Corporation, Cambridge , QC Analyst II Cell Culture, Professions , Cambridge, Massachusetts

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