The Compounder will be responsible for producing sterile product in accordance with applicable standards (e.g., cGMP, SOPs).
Safety/Housekeeping: Keep work areas clean and free of hazards or dangerous conditions Perform duties in accordance with Health, Safety, and Environmental standards. Participate in site safety programs, identify and report safety hazards or unsafe behavior
Planning: Plan work activities in accordance with production schedule, and shifting priorities Verify production schedule to determine and adjust activities according to production priorities
Technical: 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) and report all discrepancies immediately.
Accurately and completely document activities in MBR's, checklists, and all other compounding documents. Manufacture bulk pharmaceutical products. Set up equipment and perform CIP (clean in place), SIP (steam in place), mixing, filter integrity test, bulk sterilization, and sterile transfers according to SOPs, MBRs, and associated documents for assigned work area.
Accurately weigh chemicals for production, domestic, international and R&D uses. Prepare, clean, and sterilize equipment used for manufacturing of bulk product. Perform aseptic powder additions and slurry transfers to sterile bulk pharmaceutical products.
Prepare and sterilize ancillary equipment with a steam autoclave Complete required documentation in accordance with cGMP and cGDP. Troubleshoot problems with equipment/processes, alerting maintenance or supervisors as needed. Perform pH titrations: Use computerized systems in manufacturing and documenting activities
Team: Collaborate with co-workers to meet business objectives and enhance team capability. Share knowledge and experience with co-workers to develop team's overall capability.
Interfaces: Communicate and work with Quality Assurance on product quality issues and compliance activities.
Communicate and work with Maintenance to resolve problems with equipment. Exchange accurate and complete information regarding production with supervisor, other shifts, and other departments. Communicate and work with Production to ensure efficient CIP/SIP and flush flow of materials and products to/from warehouse