Production Associate I/II- Apligraf (Sunday-Thursday)

85 Dan Road, Canton, Massachusetts, 02021, United States

Job Req code 178

Category: Production

ABOUT US

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

ABOUT US

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

JOB SUMMARY 

This is an entry level position.  The Associate will perform all activities involved in the aseptic processing of a living product (Apligraf), under the direct supervision of the Apligraf Team Leader/Apligraf Supervisor/Manager.  The Apligraf Associate I will support the Apligraf Manufacturing department by performing the tasks that will assure the safe and timely processing of Apligraf, working in both a Class 100 and Class 10K cleanroom.

KEY RESPONSIBILITIES

 

  • Responsible for manufacturing Apligraf according to established Master Batch Records and Operating Procedures.
  • Responsible for the preparation of all media and sanitizing agents used in the Production areas.
  • Responsible for adherence to all Operating Procedures, protocols, policies, regulatory requirements, GMP, and safety guidelines.
  • Responsible for assuring batch records are complete and are compliant with all protocols.
  • Responsible for proper operation of all clean room equipment.
  • Responsible for maintaining all required records and adherence to established guidelines for quality control procedures, GMP’s, and safety. 

 

Requirements

JOB REQUIREMENTS

  • Sunday-Thursday schedule, approximately 7:30am-3:30pm. Some holiday work required.
  • Medium work, occasionally lifting objects up to 40 lbs.
  • Standing up to 6.5 hours/day.

SKILLS and COMPETENCIES

  • Aseptic Technique and cleanroom protocol experience
  • Basic knowledge of lab techniques
  • Ability to work in a cleanroom environment, for extend periods of time.
  • Dexterity, coordination and some lifting required

Education and experience

Associates or Bachelor’s degree in biology or related science and/or 0 - 2 years experience.  Experience in aseptic technique, GMP and clean room protocols desired.

Certificate in Biotechnology and/or a minimum of 1 - 2 years relevant experience.  Quality Systems regulations (cGMP) knowledge and clean room experience preferred but not required.