Production Associate I - Apligraf

Canton, MA

Job Req code: 944

Category: Manufacturing Operations

We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing.

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.  This position requires working in a regulated area under the direct supervision of a team leader or departmental supervisor.  This is an entry level position. The regular hours for this position are Monday-Friday, 7:30 am - 4:00 pm, with flexibility for earlier hours. Initial training will occur during early morning hours (approximately 5:00 am -6:00 am) for a period of several weeks.

Responsibilities Include:

  • Manufacture of Apligraf according to established master batch records and operating procedures
  • Assure batch records are concurrently documented, reviewed, and are cGMP compliant
  • Preparation of media and disinfectants used in the Production areas
  • Responsible for adherence to all operating procedures, policies, protocols, regulatory requirements and cGMP regulations
  • Performs 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
  • Provides 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
  • Maintains laboratory inventory supply, ensuring accurate inventory accounting
  • May write deviation reports
  • Performs related duties as directed

Requirements

  • A High School diploma or equivalent is required
  • A certificate in Biotechnology, Associate's degree, Bachelor's degree in Biology or a related science discipline 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