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Production Associate I - Apligraf (Sunday-Thursday)

Organogenesis
On-site
Canton, MA
Operations

Role 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.

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.

Qualifications

  • Certificate in Biotechnology and/or a minimum of 1 - 2 years relevant experience
  • Associates or Bachelor’s degree in biology or related science and/or 0 - 2 years experience preferred
  • Quality Systems regulations (cGMP) knowledge and clean room experience preferred but not required
  • Experience in aseptic technique, GMP and clean room protocols desired.
  • Basic knowledge of lab techniques
  • Ability to work in a cleanroom environment, for extend periods of time.
  • Dexterity, coordination and some lifting required

Education

  • Associates or Bachelor’s degree in biology or related science and/or 0 - 2 years experience preferred

Additional Requirements

  • Medium work, occasionally lifting objects up to 40 lbs.
  • Standing up to 6.5 hours/day.
  • A pre-employment physical and lift test is required for this position
  • Ability to work in a cleanroom environment, for extend periods of time.
  • Dexterity, coordination and some lifting required
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