Production Associate I

Role Summary

The Production Associate will perform activities in aseptic processing of living product or production of ICL and FortaFlex products, or activities associated with HTP product under the direct supervision of the Manager. This role supports the Manufacturing Team to assure safe and timely processing of products, working in a class 100/ISO 5, class 10K/ISO 7 and/or class 100K/ISO 8 cleanroom.

Responsibilities

• Responsible for manufacturing cellular-based products according to established Master Batch Records and Operating Procedures under aseptic conditions.
• Perform tasks related to HTP/collagen products such as layer separation, cleaning, spreading, cutting, milling, and packaging under supervision in compliance with Quality Systems regulations.
• Adhere to all Operating Procedures, Batch records, protocols, policies, regulatory requirements, GMPs, and safety guidelines.
• Review batch records for completeness and accuracy, and compliance with protocols.
• Prepare and write deviation and corrective/preventive action reports as necessary.
• Prepare all media and sanitizing agents used in Production areas.
• Rinse, segregate equipment, inspect for cleanliness, run glassware washers, and prepare equipment.
• Measure and cut tubing, prepare Production set-ups per SOPs, wrap equipment for sterilization, and sterilize equipment.
• Run depyrogenation ovens and autoclaves.
• Follow company safety policies, including bloodborne pathogen handling.
• Maintain supply inventory as directed by the production schedule.
• Operate all cleanroom equipment properly.

Qualifications

• Required: High school diploma or equivalent.
• Preferred: Bachelor's degree or Biotech certificate; knowledge of cGMP and cleanroom experience.
• Required: A pre-employment lift test and physical may be required for some positions.
• Preferred: Aseptic technique and cleanroom protocol experience.
• Required: Knowledge of standard lab techniques and equipment (balances, pipettes, stir bases, pH meters, etc.).
• Required: Ability to work in a cleanroom environment for extended periods.
• Required: Dexterity, coordination, and some lifting; ability to work independently and in a team.

Education

• High school diploma or equivalent (Required).
• Bachelor’s degree or Biotech certificate (Preferred).

Additional Requirements

• Physical: Must be able to lift up to 50 pounds; standing or sitting for prolonged periods; repetitive wrist/hand/finger motions; medium work involving moving objects up to 50 lbs; safe and conscientious work in a manufacturing environment.
• Environmental: Ability to work in a cleanroom environment for extended periods.