Manufacturing Associate

Job Description

The Manufacturing Associate transforms frozen plasma into a freeze‑dried product by operating specialized equipment in a cleanroom and highly regulated environment. This role combines hands‑on processing of blood products with detailed documentation in electronic systems, continuous improvement of procedures, and cross‑training across multiple product lines. The position offers the opportunity to contribute directly to an innovative, life‑saving biologics product that will be used in critical care and emergency settings.

• Transform frozen plasma into freeze‑dried plasma by following established processes and standard operating procedures (SOPs).
• Retrieve frozen plasma from a walk‑in freezer, load it into equipment to thaw, and transfer the liquid plasma into new bags for further processing.
• Operate the lyophilizer to remove moisture from plasma over a multi‑day cycle, monitoring the process and ensuring accurate handling and labeling.
• Repackage and kit freeze‑dried plasma in the kitting room according to written procedures and quality standards.
• Track every unit of product accurately in the BECS system, ensuring complete and precise data entry in production records.
• Manufacture, inspect, and package products by following written processes and using appropriate equipment for visual, dimensional, time, and documentation checks.
• Work at a pace that meets or exceeds established time standards while consistently producing high‑quality product.
• Identify and report quality issues or workmanship deficiencies related to equipment, assembly and inspection processes, materials, sub‑assemblies, or the manufacturing environment.
• Comply with Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) requirements by maintaining individual training records and completing all documentation accurately and on time.
• Review, follow, and help improve production procedures, including redlining documents to support continuous process improvement.
• Maintain a clean, safe, and organized work environment in both the cleanroom and desk‑based work areas.
• Champion a safety‑driven culture and ensure compliance with all safety and environmental regulations, policies, and procedures.
• Cross‑train across multiple product lines to support flexible manufacturing needs.
• Train other operators on applicable manufacturing procedures and the proper use of production equipment, as needed.
• Communicate effectively with team members and leadership regarding production status, issues, and improvement opportunities.
• Meet quality and labor time targets while multitasking and switching between tasks as required.
• Perform other duties as assigned to support production, quality, and continuous improvement goals.

• At least 6 months of experience working under Good Manufacturing Practice (GMP) requirements.
• At least 6 months of Good Documentation Practice (GDP) experience with proven ability to document accurately and completely.
• Minimum 6 months of relevant experience in biologics, pharmaceuticals, or medical devices.
• Understanding of and adherence to standard operating procedures (SOPs).
• Experience in a highly regulated environment.
• Strong computer literacy, including the ability to log information into electronic systems such as a BECS system.
• Ability to read and understand policies, procedures, and processes written in English.
• Effective oral and written communication skills.
• Demonstrated responsibility for accurate documentation in a highly regulated environment.
• Ability to think critically and make decisions independently within defined procedures.
• Capability to train operators on manufacturing procedures and production equipment.
• Ability to multitask and switch between tasks frequently while maintaining accuracy and quality.
• Physical ability to sit frequently, stand, walk, bend, occasionally lift, and move in and out of a walk‑in freezer.
• Demonstrated ability to achieve quality and labor time targets.

• Background or degree in biology, laboratory science, or a related field.
• Experience with blood products, biologics, or similar materials.
• Experience in cleanroom manufacturing…