The Product Formulation Technician is responsible for operating compounding equipment and may be required to work in both the Commercial formulation area, as well as, the Development formulation area. Responsibilities also include following necessary methods and procedures to produce a functional compounding process. The Product Formulation Technician ensures that documentation and activities in the compounding area are compliant with any applicable regulations.

Commercial Responsibilities:

• Assist the Aseptic Processing Manager in establishing SOPs as needed.
• Satisfy the compounding equipment operation, calibration, and cleaning requirements.
• Keep a clean, safe, productive, and orderly staging, dispensing, and compounding area.
• Assist in sampling and weighing of chemicals required to support product formulation.
• Perform validation methods on the compounding equipment.
• Perform filter testing on sterile filters and maintain logbooks.
• Responsible for batch compounding according to TRC Documents and Protocols.
• Responsible for the pre and post cleaning and steaming of the compounding equipment.
• Perform routine maintenance on equipment.
• Responsible for cross-training with the Dispensing Department.
• Follow SOPs safety, health and cGMP guidelines.

Development Responsibilities:

• Assist the Product Development Engineer in developing safe and efficient functional procedures and work instructions in support of new formulation processes.
• Operate equipment in the formulation of new products and new processes to support formulation and equipment studies, and validation activities.
• Perform the sampling of raw materials when necessary and obtaining the tools and instruments required to support operation of the process.
• Formulate GMP Development Batches for Validations, Clinical Distribution and FDA Regulatory filings in compliance with TRC Batch Record instructions, Procedures and Policies.

Physical Requirements:

• Ability to push and pull extremely heavy tanks and lift and carry up to 40 pounds of equipment, parts or supplies.
• Ability to wear a respirator.
• Ability to stand while working for 12 hour shifts.

Qualifications:

• High School diploma or GED
• 0-2 years experience in a regulated laboratory environment
• Knowledge of cGMP Guidelines
• Ability to participate and develop a team-oriented working relationship
• Ability to prioritize task with minimal supervision
• Must possess very good oral and written communication