Responsible for compounding high-quality solutions, semi-solids, and suspensions in accordance with Good Manufacturing Practices (GMP) and department Standard Operating Procedures (SOP).
This position is responsible for the following:
- Accurate formulation of products.
- Stage, load, operate, and monitor all equipment for product formulations.
- Weighing and mixing chemicals according to specific formulas.
- Calibrate, operate, and monitor all formulation-related equipment (e.g., mixers, scales, meters, etc.).
- Perform operations necessary to adjust the pH of product for in-process testing.
- Clean, steam, and sanitizes all tanks, facilities, equipment and chemical containers used in the product formulation process in accordance with current SOP’s and cGMP’s.
- Accurately complete documents and record production volumes (batches) in compliance with current GDP standards.
- Assumes other duties and responsibilities, as necessary, within the Compounding department, in an effort to provide the required support to ensure adherence to the production schedule.
Incumbent has full authority to make decisions and/or take action that is required to carry out job duties. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be willing to take temporary assignments as required.
Regulated Responsibilities (including cGMP and EHS)
Incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.
Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.
- Frequently works with hot water and steam.
- Frequently walks on slippery or uneven surfaces.
- May handle and transport Hazardous and Non-Hazardous material.
- May climb stairs or use ladders and work off elevated surfaces on an occasional basis during each shift.
- Noise level in the work environment is frequently loud but managed below the acceptable OSHA regulated level.
Education and Experience:
Essential Knowledge, Skills & Abilities:
Significant Work Activities: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced