Production Associate I

Role Summary

Production Associate I in a regenerative medicine/advanced wound care environment. Responsible for manufacturing cellular products and supporting aseptic processing, with work in cleanrooms and adherence to GMPs and safety guidelines. Roles may include work on HTP and collagen products under supervision, with various shifts and possible weekend/holiday requirements.

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 with supervision in compliance with Quality Systems regulations.
• Adhere to Operating Procedures, Batch records, protocols, regulatory requirements, GMPs, and safety guidelines.
• Review batch records for completeness and accuracy and compliance with all protocols.
• Prepare media and sanitizing agents used in Production areas; manage rinsing, equipment preparation, and cleanliness checks.
• Prepare production set-ups, wrap equipment for sterilization, and sterilize equipment; operate depyrogenation ovens and autoclaves.
• Adhere to company safety policies, including bloodborne pathogen handling.
• Maintain supply inventory as directed by the production schedule and ensure proper operation of clean room equipment.

Qualifications

• High school diploma or equivalent required.
• Bachelor‚Äôs degree or Biotech certificate, knowledge of cGMP and clean room experience preferred but not required.
• A pre-employment lift test and physical may be required for some positions.
• Aseptic technique and cleanroom protocol experience desired.
• Knowledge of standard lab techniques and equipment (balances, pipettes, stir bases, pH meters, etc.).
• Ability to work in a cleanroom environment for extended periods.
• Dexterity, coordination, and some lifting required; ability to work independently and in a team.

Skills

• Cleanroom operations
• Aseptic technique
• Batch record review
• Equipment sterilization and operation
• Quality systems and GMP compliance

Education

• High school diploma or equivalent required; additional biotech coursework or degree preferred.

Additional Requirements

• Physical: ability to lift up to 50 pounds; ability to stand or sit for prolonged periods; repetitive motions.
• Environment: work in cleanroom with extended exposure; potential weekend/holiday shifts.