Production Associate I - Apligraf

Canton, MA

Job Req code: 701

Category: Production

Organogenesis is a leader in regenerative medicine focused on empowering healing through the development, manufacturing and sale of products for the advanced wound care, and surgical and sports medicine markets. Our Canton, MA headquarters has an opening for a full time (40 hours) Production Associate I on our Apligraf manufacturing team. We offer a strong benefits package, opportunities for growth, and the chance to contribute to our mission: to provide an integrated portfolio of healing solutions that improve lives while lowering the overall cost of health care.

The Production Associate I is an entry-level position reporting to the Manager, Apligraf Production and works a Monday-Friday schedule, approximately 7:30am - 4:00pm, with flexibility for earlier hours. Initial training will be held approximately 5:00am -6:00am for a period of several weeks. Some holiday work is required. This is a non-exempt position per the Fair Labor Standards Act (FLSA).

Key responsibilities:
The Production Associate I performs all activities involved in the aseptic processing of a living product (Apligraf).  This individual supports the manufacturing department by performing tasks that will assure the safe and timely processing of Apligraf. The position requires working in a regulated area under direct supervision.

  • Manufacture Apligraf according to established master batch records and operating procedures
  • Assure batch records are concurrently documented, reviewed, and are cGMP compliant
  • Prepare of media and disinfectants used in the Production areas
  • Adhere to all operating procedures, policies, protocols, regulatory requirements and cGMP regulations
  • Perform all tasks in compliance with company safety policies especially involving chemical safety and proper lifting techniques 
  • Responsible for proper operation of all clean room equipment
  • Provide assistance with process optimization and scale-up activities, if necessary
  • May provide assistance to Engineering and Facilities Departments, as necessary, for equipment operation during calibration, validation, or repair
  • Maintain laboratory inventory supply, ensuring accurate inventory accounting
  • May write deviation reports
  • Related duties as directed

Requirements

Preferred education and experience:

  • A High School diploma or equivalent is required
  • A certificate in Biotechnology or an Associate's degree is preferred
  • Prior experience in general lab techniques, aseptic technique, GMP and clean room protocols is desired
  • Ability to work in a cleanroom environment, for extend periods of time
  • Dexterity, coordination, and some lifting is required