Associate , Production Systems

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Processing Full Time Mfg, EHS Miami, FL, US

Salary Range: $39,681.00 To $47,617.00 Annually

At Bio Tissue, we transform the gift of life by sharing miracles. We are a diverse community, where talent and teamwork are core to who we are. Here, you are EMPOWERED to do the work you love, be yourself, and make an impact. Resilient and committed to our vision, we embrace challenges, celebrate courage, and take great pride in our work to create life-changing products.

Purpose led us here. Passion and legacy keep us going.

Associate I, Production Systems supports manufacturing operations by preparing materials, documentation, equipment, and production support activities in a regulated GMP environment. This role follows approved procedures to support safe, compliant, and efficient processing of HCT/P and related products. The position contributes to Safety, Quality, Delivery, and Cost performance by maintaining organized, audit-ready work areas; supporting right-first-time documentation; preparing materials and records for scheduled production;

reducing waste and rework; and escalating risks in a timely manner. This position reports to the Lead Associate, Manufacturing and provides a foundation for progression to Associate II and Associate III roles.

• Perform routine inventory checks of production materials, supplies, and consumables; communicate shortages, risks, or restock needs.
• Prepare processing carts, raw materials, documentation packets, labels, tools, and supplies in accordance with the production schedule and approved procedures.
• Support Safety initiatives by following PPE, gowning, hygiene, ergonomic, chemical handling, biohazard waste, 6S, and housekeeping requirements.
• Identify and report unsafe conditions, hazards, near misses, equipment concerns, or facility issues in a timely manner.
• Support Quality initiatives by following SOPs, work instructions, cGMP, GTP, GDP, ISO, and aseptic technique requirements.
• Review assigned work for accuracy prior to handoff and elevate documentation, material, process, or potential deviation concerns.
• Support Delivery initiatives by completing assigned tasks on time, preparing materials and records in advance, and communicating barriers to schedule execution.
• Support Cost initiatives by using materials responsibly, minimizing scrap and rework, preventing documentation errors, and identifying opportunities to improve flow.
• Clean, package, stage, and submit reusable instruments, equipment, and materials for sterilization or processing support.
• Pack, organize, label, and stage final product requiring sterilization, quarantine, storage, or transfer to Supply Chain.
• Transfer, thaw, stage, or handle placental tissue and related materials while maintaining product identification, traceability, and integrity.
• Create, stamp, organize, and prepare Batch Production Records, logs, labels, requisitions, work orders, and other GMP documentation.
• Complete requisitions for quality control samples and submit samples to the designated laboratory as required.
• Complete accurate, legible, and timely documentation, including batch records, cleaning logs, equipment logs, inventory forms, and system entries.
• Participate in daily huddles, shift handoffs, Tier 1 discussions, training activities, metric awareness, and continuous improvement activities as assigned.
• Perform administrative and production support duties, including filing, copying, scanning, archiving, record organization, label preparation, and handling confidential documents.

• Strong attention to detail and ability to follow approved procedures, documentation practices, and quality expectations.
• Ability to work safely in a regulated manufacturing, laboratory, or cleanroom environment.
• Awareness of Safety, Quality, Delivery, and Cost priorities, with the ability to recognize risks and communicate issues promptly.
• Good verbal and written communication skills, including accurate task status updates and timely escalation of concerns.
• Ability to prioritize assigned tasks and adapt to changing production needs.
• Working knowledge of inventory control, material staging, documentation handling, and production support practices preferred.
• Ability to support 6S, visual management, daily huddles, waste reduction, right-first-time…