Aseptic Prep Operator

Position Summary:

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 and packaging/inspection personnel to ensure workflow does not stop due to material availability, and proactively helps drive overall operational efficiency.

Essential Functions:

• 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 utilizes Enterprise Resource Planning (ERP) software to modify virtual inventory, maintain inventory levels, and identify/resolve material availability issues
• May utilize QMS software to document work performed, upload documents, or convey information in accordance with cGMP requirements
• May perform high-level cleaning/disinfecting of sterile cleanrooms
• Provides input and support to ensure availability of raw materials
• Reviews documentation for accuracy, makes corrections and/or escalates to supervision/MQA
• May puts items into stock (physical), performs cycle counts, supports physical inventory counts at required frequency as needed.
• May transport recycling and packaging waste to final on-site disposal location
• Maintains all personal cGMP related training in a current state
• Observes all environmental, health, and safety policies
• Performs other duties and tasks as assigned by management

Education and Experience:

• High school diploma or equivalent required.

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

Knowledge, Skills and Abilities:

• 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

• Must be dependable/reliable/punctual, minimal unexcused absences if internal applicant

Physical Requirements:

• Routine standing