Responsible for creating, formatting, and improving compounding department Standard Operating Procedures (SOP) and Procedures required for manufacturing base on cGMP.
This position is responsible for the following:
- Create Manufacturing documents as required by new product formulations.
- Revise Manufacturing Processing Procedures based on organizational needs/requirements.
- Track all changes required and submit within Global Trackwise (as applicable) on time and Right First Time (RFT)
- Improve document flow for ease of use to operators during manufacturing reducing the potential for documentation errors.
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.
Education and Experience:
Essential Knowledge, Skills & Abilities:
- Ability to perform detailed tasks and document activities completely and accurately.
- Ability to think and plan in a logical sequential order.
- Ability to work any shift (up to 12-hours) as required dependent on business needs.
- Ability to read, comprehend, write, and communicate effectively in English.
- Ability to carry out detailed written or oral instructions.
- Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
- Basic user knowledge and understanding of Windows-based computer systems such as Microsoft Office, with an ability to learn other computer-based systems.
Significant Work Activities: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced