Product Formulation Technician - Suspension

The Product Formulation Technician-Suspensions 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-Suspensions ensures that documentation and activities in the compounding area are compliant with any applicable regulations.

Level 0

• New Hire

Level 1

• Product Formulation job code COMP 1 training completed and assessment passed
• Product Formulation job code DISP1 training completed and assessment passed
• Product Formulation BUD job code training completed and assessment passed
• Product Formulation job code BUD-V training completed and assessment passed
• Product Formulation job code Isolator training completed and assessment passed

(OR)

• Product Formulation job code Cyclo training completed and assessment passed
• Prod Formulation job code Small Scale Equip training completed and assessment passed.

Level 2

• Product Formulation job code COMP 1 training completed and assessment passed
• Product Formulation job code DISP1 training completed and assessment passed
• Product Formulation job code Cyclo training completed and assessment passed
• Product Formulation job code BUD training completed and assessment passed
• Product Formulation job code BUD-V training completed and assessment passed
• Product Formulation job code Isolator training completed and assessment passed
• Product Formulation job code Small Scale Equip training completed and assessment passed
• Product Formulation job code Lab Equip training completed and assessment passed

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.
• Perform in-process testing and data entry into LIMs.
• 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.
• 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.
• Responsible for cross-training with the Dispensing Department.
• Perform additional duties as assigned by management.
• Follow SOPs safety, health and cGMP guidelines.
• Work hours will be on rotating 12 hour shifts as production demands.

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.

• 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