Production Associate I - Fortaflex

Canton, MA

Job Req code: 694

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 Production Associate I to join the FortaFlex 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 - FortaFlex assists in the performance of routine operations for the GMP production of FortaFlex  and ICL products. This individual operates in accordance with environmental, health, safety, and cGMP guidelines.  The Production Associate reports to the Fortaflex  Manager. This position works a Monday-Friday, 7:30am-4:00pm schedule. This is a non-exempt position per the Fair Labor Standards Act (FLSA).

Responsibilities include the following:  

  • Performing all tasks (lay-up, trim, cross-linking and packaging) for the production of FortaFlex Products under supervision and in compliance with Quality Systems regulations and according to established procedures
  • Preparing solutions for use within the production areas
  • Reviewing batch records for completeness and accuracy as well as compliance with all protocols
  • Maintaining all equipment records
  • Maintaining supply inventory
  • Writing deviations and corrective/preventive action reports
  • Performing all tasks according to company safety policies
  • Other duties as assigned
     

Requirements

Preferred education and experience:

  • A High School diploma or equivalent is required
  • Bachelor's degree, Associates degree, Certificate in Biotechnology or other advanced education is preferred 
  • Must have the ability to lift up to 50 pounds
  • Must be able to work in a controlled or clean room environment for an extended period of time
  • Must have the ability to work safely and conscientiously in a manufacturing environment

A pre-employment physical and lift test is required for this position.

Physical activities:

  • Remaining in a stationary position, often standing or sitting for prolonged periods
  • Communicating with others to to exchange information
  • Repeating motions that may include the wrists, hands and/or fingers
  • Assessing the accuracy, neatness, and thoroughness of the work assigned

Physical demands:

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 
  • Medium work that includes moving objects up to 50 lbs.

Environmental conditions:

  • No adverse environmental conditions expected.