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QC Analyst II

Company: Vericel Corporation
Location: Cambridge
Posted on: November 19, 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.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 Control 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 Senior Manager, QC Microbiology -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: 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 microbiological assays for in-process and final product samples.
  • Perform analytical methods for final bulk material/finished goods.
  • 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.
  • 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.
  • Master core responsibilities of a QC Analyst I.
  • Other duties as assigned. QUALIFICATIONS, EDUCATION AND EXPERIENCE Leaderships Qualifications:Leadership qualifications include, among other requirements:
    • Understanding, observing, and adhering to the goals and policies outlined in Vericel's Code of Business Conduct and Ethics
    • 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.
    • Serving as role models for our fellow employees and business partners 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, MS with 0-1+ years of experience in a lab setting.
      • 2+ years of experience in one or more of the following disciplines: microbiology, cell biology and cell culture, 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 environmental monitoring in a clean room environment.
        • 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.
          • 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, Professions , Cambridge, Massachusetts

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