Aseptic Preparation Operator

Job Title

Responsible for preparing batch specific materials inside and outside of the cleanroom. Transports materials, supplies, and finished products to designated locations. Works with planning/scheduling and incoming warehouse to assist in reviewing inventory levels and identify/resolve material availability issues. Operates parts washers, sterilizers, autoclaves. Collaborates with production to ensure workflow does not stop due to material availability and proactively helps drive overall operational efficiency.

• Prepares batch specific materials (staging) inside and outside of the cleanroom.
• Maintains full gown and garb qualification
• Retrieves, prepares, stages, and delivers materials and supplies to production, packaging & inspection (finishing), and distribution center.
• Operates parts washers, sterilizers, autoclaves, and other relevant equipment
• Communicates frequently and works inclusively with Team Leads, Supervisors, Scheduling, MQA, Training and other site personnel to meet the goals of the production department.
• Complies with all federal, state, regulatory bodies (FDA, DEA, BOP, DEC, OSHA) and local municipalities.
• Meets site goals and objectives as part of a team
• Initiates and fosters a spirit of cooperation within and between departments
• May perform high-level cleaning/disinfecting of sterile clean rooms
• May put items into stock (physical), perform cycle counts, supports physical inventory counts at required frequency as needed.
• May transport recycling and packaging waste to final on-site disposal location
• Observes all environmental, health, and safety policies
• Performs other duties and tasks as assigned by management
• Maintains proper documentation in appropriate logbooks and batch records.
• Qualified in or must become qualified in 1-5 processes outlined in the Operations Growth Chart.

- High school diploma or equivalent required.

- Prefer two years experience in a related field (manufacturing or pharmacy)

- Good interpersonal skills and willingness to work with others

- Good oral and written communication skills

- Good organizational skills and attention to detail

- Ability to prioritize tasks

- Ability to work effectively both as part of a team and individually

- Ability to give/receive constructive criticism