The Compounder/ Machine Operator is responsible for the accurate weighing, checking and verification when mixing specific compounds for product formulation in a clean room environment. Performs monitoring of mixing and formulation and filling. Routinely complies with cGMP's, departmental SOP's and company policies and maintains accurate documentation for each batch manufactured.
- Safely operate and properly adjust, assemble/disassemble, clean and set-up all equipment utilized in the filling of product containers
- Weighs out and mixes precise amounts of raw materials according to specific formulas and monitors (verifies) product output from mixing operations.
- Produce sterile products, in accordance with applicable standards and procedures (cGMP, SOPs, etc.). Strictly adhere to Current Good Manufacturing Practices (cGMP), Current Good Documentation Practices (cGDP), and Standard Operating Procedures (SOP's) an
- Clean and sanitize equipment and chemical containers used in the product formulation process in accordance with SOP's
- Perform daily, weekly and monthly department cleaning and sanitation
- Determine material requirements to complete the established production schedule and timeliness in requisitioning these materials from RM inventory to avoid delays in operations.
- Assemble materials and operate filling equipment to produce filled In-Process products and in some cases pack Finished Good products per the Bill of Material and written production operations work instruction.
- Inspect filled product components and packaging materials for general acceptance of appearance (i.e. caps tight, container is clean, print and labels are readable), perform filled product QC checks (fill weight) and packed product final Packaging Inspection.
- Develop a working understanding of their Quality System - (i.e. Quality Policy, ISO Documentation System, Product traceability & record keeping).
- Maintain detailed and accurate written records for items such as material lot numbers, quantities, cycle count results, batch records and daily labor reports.
- Collect fill-weight and other data both on automated laptop computer connections and paper check sheets.
- Follow all Department and Plant safety rules and GMP guidelines.
- Maintain the 5S work area organization standards for the assigned Production work areas.
- Ability to assist in all areas of prior skill or knowledge, accept training in new areas and perform other duties as assigned by production supervision.
- Participate in TQM improvement and KI activities.
- Other duties as assigned.