Production Associate III-Solutions Prep

Role Summary

The Production Associate III-Solutions Prep prepares sterile and non-sterile solutions in an ISO 7 clean room according to established procedures. They assist with ensuring task clarity and timely completion, coordinate training or onboarding for the Solution Prep team, and maintain training files and biennial document updates, working closely with the Supervisor and/or Manager.

Responsibilities

• Prepare all solutions according to established Master Batch Records and Operating Procedures, including measuring chemicals, mixing, pH/osmolality assessment, aseptic dispensing, and line clearance.
• Ensure batch records are complete and compliant with all protocols.
• Coordinate training of new personnel and update Solution Prep associates; schedule, perform (where applicable), and document training; maintain personnel training records.
• Assist with aseptic requalification and annual re-certification of team members; participate in the semi-annual Aseptic Process Simulation Re-Validation.
• Maintain the ISO 7 laboratory area, including cleaning of equipment, monthly equipment logs, and FIFO management of glassware, chemicals, and autoclaved materials.
• Adhere to all Operating Procedures, Protocols, Regulatory Requirements, GMP, and Safety Guidelines.
• Participate in ordering supplies for the Solution Prep area and hazardous waste disposal.
• Write and revise manufacturing documents and procedures, ensuring biennial review compliance; maintain records and adhere to Quality Control procedures, cGMP, and Safety.
• Assist in deviation investigations and CAPAs as needed.

Qualifications

• Required: B.S. or A.S. in Biological Science or equivalent, with 3–5 years of relevant experience.
• Preferred: Aseptic skills are highly desirable.
• Preferred: Experience in Solution Preparation or GMP manufacturing (3+ years).
• Preferred: Proficiency with computers (MS Excel, MS Word, ERP system); knowledge of cGMP and clean room experience.

Education

• B.S. or A.S. in Biological Science or equivalent

Skills

• Ability to work in a clean room environment
• Work as a member of a team as well as independently
• Problem solving skills
• Manual dexterity
• Heightened awareness and attention to detail
• Scientific and technical knowledge
• Proficiency in applying new and existing technologies
• Communication skills
• Writing skills
• Basic computer skills with Word and Excel
• Organizational and documentation skills
• Knowledge of an electronic documentation system (e.g., Smart Solve)
• Taking initiative
• Proven leadership ability

Additional Requirements

• Ability to lift and move objects in excess of 25 lb