Job Description: The Dispensing Operator is responsible for the dispensing of raw materials (liquids powders hazardous and non-hazardous substances acids and bases) under cGMP conditions to support the manufacture of therapeutic proteins (API). The role requires strict adherence to safety aseptic techniques and regulatory compliance to ensure accurate preparation handling and documentation of all materials. The individual will monitor dispensing processes operate equipment perform basic laboratory tasks and ensure that all activities are performed per established procedures (SOPs) Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDPs).
Responsibilities: - Perform and monitor dispensing of raw materials (liquids powders acids bases) in compliance with cGMP.
- Demonstrate aseptic technique contamination prevention and adherence to safety standards.
- Follow SOPs to execute process recipes and document activities per GDP requirements.
- Operate clean and sanitize dispensing equipment; perform scheduled maintenance as required.
- Conduct peer and first-level review of completed dispense orders/kits.
- Perform basic laboratory tests (e.g. pH conductivity sampling) as needed.
- Prepare and transport materials to manufacturing suites including physical and system-based movements.
- Participate in safety inspections and submit safety observations to improve workplace conditions.
- Attend shift exchanges meetings and complete assigned administrative tasks.
- Support logistics and related team activities as needed.
Requirements: - Associates degree in a relevant field (Science Engineering or related discipline) OR equivalent experience.
- Prior experience in a cGMP-regulated environment preferred (dispensing manufacturing or laboratory operations).
- Ability to qualify for assigned tasks and maintain a compliant training record.
- Basic understanding of cGMP compliance aseptic handling and cross-contamination prevention.
- Familiarity with Good Documentation Practices (GDPs).
- Ability to operate clean and sanitize dispensing equipment.
- Strong attention to detail and accuracy in material handling and documentation.
- Effective communication skills both written and verbal.
- Ability to work in a Class C cleanroom environment with full gowning and PPE.
- Basic computer literacy and ability to use electronic systems for documentation (e.g. eDispense).
- Team-oriented with strong problem-solving skills and commitment to workplace safety.