Production Associate - Apligraf & Cell Culture Depts.

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APLIGRAF:  Works with minimal supervision performing all aspects of Apligraf manufacturing, including media production, according to established MBRs and SOPs under cGMPs within the Class 10,000 & Class 100 clean rooms using aseptic techniques.  The job requires attention to detail and good documentation practices.  Extensive time will be spent within the clean room laboratories with additional documentation responsibilities required outside the lab.  Responsible for ensuring that a quality Apligraf product is available to meet all customer requirements.

Requires High School diploma.  A biotechnology certificate and/or degree in science field is a plus.

CELL CULTURE:  As an entry-level position, this Associate will manufacture HEP & HDF cells under direct supervision from a team leader or supervisor.  The Production Associate I will perform all tasks required to produce cells, i.e. spinner preparation, seed, maintain, harvest cells, in a level 10,000 clean room environment in a safe and timely manner.  This associate will also assist in the cell banking process when required.

Responsibilities Include:
• Responsible for manufacturing cells according to established MBR’s and OP’s
• Responsible for adherence to all OP’s, protocols, policies, regulatory requirements, GMP, and safety guidelines
• Responsible for assuring cell culture paperwork is complete and compliant with all protocols
• Responsible for proper operation of all clean room equipment
• Responsible for maintaining all required records & adherence to established guidelines for QC procedures, GMP’s and safety.
• Assist in developing, collecting, trending, and analyzing cell culture technical data

Skills and Competencies:
• Basic computer skills
• Ability to work independently as well as in a team environment
• Manual dexterity
• Aseptic technique, basic lab techniques (ex:  pipettes, balances, etc…)
• Ability to work in a clean-room environment for extended periods

Education and Experience:
Associate or Bachelor’s degree in biology or related science with 0-2 years experience.  Experience in aseptic technique and clean room protocols desired.  Certificate in biotechnology and minimum of 1-2 years of relevant experience.

APPLY DIRECTLY TO OUR WEBSITE AT: www.organogenesis.com