What are the responsibilities and job description for the Aseptic Prep Operator position at Pine Pharmaceuticals?
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
Salary : $19