Description:

The Manufacturing Product and Packaging Operator I plays a vital role in the daily production of medical devices, ensuring compliance with current Good Manufacturing Practices (cGMPs), customer requirements, and Standard Operating Procedures (SOPs). Responsibilities include reviewing batch records and amendments, setting up and verifying calculation data, preparing and verifying test materials before dose administration, and accurately performing procedures with proper documentation. This entry-level role operates under direct supervision, following established procedures to execute production and meet project deadlines.

Essential Functions:

• Completes a variety of assignments under direct supervision based on established procedures including performing experiments to pilot/scale-up/ANDA batches and process optimization of oral dosage form unit operations using FDA's quality by design and well-experimental design approaches.

• Summarizes data in reports; records document experimental work/in-process testing accurately utilizing established best practices.

• Communicates with good writing and critical analysis skills and presents process optimization and trouble-shooting activities, findings and recommendations to his/her supervisors.

Additional Responsibilities:

• Responsible for all applicable documentation, creating and maintaining activity records and requirements.