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Production Associate I - Fortaflex

Organogenesis
On-site
Canton, MA
Operations

Role Summary

The Production Associate I will be performing the production of ICL and FortaFlex products under supervision. The associate will adhere to the appropriate SOPs, MBRs, and cGMP procedures in the general lab area as well as the ISO 7 clean room.

Responsibilities

  • Performing all tasks (lay-up, trim, cross-linking and packaging) for the production of FortaFlex Products, and all tasks (slitting, washing, and packaging) for the production of the ICL intermediate, 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

Qualifications

  • Required: High School diploma or equivalent
  • Preferred: Associate’s degree, Certificate in Biotechnology or other advanced education
  • The regular schedule is Monday–Friday 6:30 am–3:00 pm
  • Assessing the accuracy, neatness, and thoroughness of the work assigned

Education

  • High School diploma or equivalent (required)
  • Associate’s degree, Certificate in Biotechnology, or other advanced education (preferred)

Additional Requirements

  • Environmental Conditions: Must be able to work in a controlled or clean room environment for an extended period
  • Physical Requirements: Pre-employment physical and lift test; pre-employment vision screening; ability to lift 50 pounds, push/pull ≥400 pounds (200 L); ability to work in a controlled or clean room environment for an extended period; stationary or standing for prolonged periods; repetitive motions of wrists/hands/fingers; safety-conscious in a manufacturing environment