Production Support Associate (Human Tissue)

About the Role

The fundamental role of a Production Support Associate is to be knowledgeable in all processes to support product manufacturing such as cleaning, sterilization, material handling, facility support, documentation, and other production support activities in accordance with cGMP, cGTP, FDA regulations, AATB Standards, ISO requirements, and company procedures.

Responsibilities

• Process cleanroom supplies, equipment, and instruments through decontamination, inspection, assembly, labeling, wrapping, sterilization, and appropriate storage.
• Prepare and label disinfectant solutions and reagents in accordance with Good Documentation Practices (GDP).
• Assist with material movement, inventory replenishment, and supply management activities.
• Support Production Technicians with operational activities, including label printing, nitrogen tank exchanges, material preparation, and the aseptic transfer of processing supplies.
• Transfer donor tissue and tissue residuals between storage locations while maintaining chain of custody and traceability.
• Follow safety protocols, to include Bloodborne Pathogen, Hazard Communication, waste handling, and environmental safety procedures.
• Dispose of biohazardous waste in compliance with EPA and OSHA guidelines.
• Decontaminate processing areas according to established SOPs.
• Report safety concerns, incidents, and deviations promptly and accurately ensuring no injury to self/others.
• Complete production records, logs, forms, and documentation in accordance with Good Documentation Practices (GDP) and ALCOA principles.
• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures.
• Maintain acceptable attendance and punctuality for scheduled work hours and meetings.
• Ensure completion of assigned tasks and responsibilities within defined timeframes.
• Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary.
• Perform other duties as assigned.

Skills

• Ability to work independently and collaboratively in a team environment.
• Strong attention to detail and organizational skills.
• Effective written and verbal communication skills.
3li> Demonstrated integrity and ethical judgment.
• Ability to model and reinforce safe, compliant workplace behaviors.
• Ability to prioritize multiple responsibilities in a fast-paced environment.
• Basic technical writing skills.
• Ability to complete documentation accurately and legibly.
• Proficiency in Microsoft Office.
• Ability to maintain required training and competency qualifications.

Physical Requirements

• Ability to stand and perform assigned duties for extended periods.
• Ability to lift and carry up to 25 pounds.
• Ability to perform repetitive cleaning and material-handling activities.
• Ability to wear required PPE and cleanroom attire for extended periods.
• Ability to safely operate a company vehicle with an acceptable driving record.

Qualifications/Requirements

• High school diploma or equivalent from an accredited institution required.
• Previous experience in a regulated medical, manufacturing, laboratory, or cleanroom environment preferred.
• Valid Class C driver’s license.
• Clearance of favorable background investigation required.