Production Associate I/II - Fortaflex

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

Job Req code 136

Category: Production

The FortaFlex Production Associate I/II will be performing the production of ICL and FortaFlex Products with supervision. The associate will adhere to the appropriate SOP’s, MBR’s, and cGMP procedures in the general lab area as well as the Class 10,000 clean room. The FortaFlex Production Associate I will report to the FortaFlex Supervisor.


KEY RESPONSIBILITIES · Perform all tasks, eg. lay-up, trim, cross-linking, diecutting, and packaging, for all FortaFlex products with supervision in compliance with QS regulations and according to established procedure. · Perform all tasks, eg. slitting, transfers, filter testing, and bagging, for the production of ICL with supervision with supervision in compliance with QS regulations and according to established procedure. · Prepare all media for use within the Production areas with supervision. · Prepare equipment for autoclaving and autoclave equipment. · Review batch records for completeness and accuracy as well as compliance with all protocols. · Maintain all equipment records. · Perform all tasks adhering to company safety policies. · Maintain supply inventory. · Responsible for the writing of deviation and corrective/preventive action reports, as necessary.

Job Requirements: 
·           Operation of general lab equipment and general lab techniques (eg. balances, pipettes, stir bases, and pH meters).
·           Lifting 50 lbs.· Pushing/pulling < 400 pounds (200 L)· Manual dexterity.
·           Ability to work independently as well as in a team environment.
·           Ability to work in a cleanroom environment for extended periods of time.
·           Certificate in Biotechnology preferred but not required and/or a minimum of 1-3 years of relevant experience.
·           Aseptic technique and clean room protocol experience desired.


Skills Required: