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Vericel Corporation Quality Control Analyst, Senior in Cambridge, Massachusetts
Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Medical Affairs professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. 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. DUTIES Perform microbiological, molecular and/or cell culture assays for in-process and final product samples Participate in transfer methodology from other groups and may maintain complex equipment. Author reports, SOPs and other documentation for quality testing and/or equipment. Provide training and technical leadership to less experienced staff. Participate in and/or perform laboratory investigations and non-conformance deviations. Perform finished product review and lot release. May manage departmental projects. Participate in the execution of corrective and preventative action plans as well as the initiation and follow through for change controls. Exercise judgment and decision making when problem solving Communicate inter-departmentally and with external contracts to solve technical issues. Other duties as assigned Basic Qualifications Bachelor\'s Degree + minimum 5+ Years relevant industry experience in CGMP lab environment, or equivalent Master\'s Degree + minimum 3+ Years relevant industry experience in CGMP lab environment, or equivalent Experience as a technical leader in a strong team environment and work independently to successfully balance short and long term project objectives. WORKING CONDITIONS AND PHYSICAL DEMANDS Ability to lift 40 lbs. Required to work one day per weekend. Rotating holiday coverage May carry company issued cell phone for off-shift remote alarm coverage Required to gown into classified manufacturing ISO 7 clean room areas