Job Description
A prestigious company is seeking motivated Cell Processing Associates, who will work within a team to produce the highest standard of product for patients who are being treated with the company's immunotherapy prostate cancer vaccine. Successful candidates must be able to understand and keep to standard operating procedures (SOP) that include, but are not limited to, aseptic technique, clean-room operations, gowning and operator qualifications. Exemplary associates must be precise and rigorous when performing review of their own work and others. Data entry without errors enables Quality and all other support groups to accurately assess, approve and deliver final product to patients in a timely fashion.
Responsibilities: Performs a wide variety of activities which may include one or more of the following:
' Aseptic manufacturing and assembly of clinical and commercial human blood derived components in a clean-room environment (Class 10,000/ISO7 and Class 100,000/ISO8). ' Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and quantities. ' Maintains records and clean room environment to comply with regulatory requirements, good manufacturing practices and aseptic processing of clinical and commercial products using Standard Operating Procedures. ' Assists with validating processes and equipment that are directly related to filtration, cleaning and sterilization. ' Provide general upkeep of gowning and supplies for the clean-room in manufacturing areas. ' May mentor other Cell Processing Associates. ' Represents department in cross-functional teams, projects and GXP related problem resolution.
Job Requirements: ' Associate's or Medical Technical degree or equivalent. ' Typically 1 year related experience in CGMP/FDA regulated industry. ' Proficient in MS Office applications. ' Ability to gown aseptically for work in a Clean Room environment. ' Extensive use of laboratory equipment, chemicals and biological materials. ' Ability to lift 50lbs unassisted.
Job Requirements
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