Aseptic Product Formulation Technician – Suspensions

The Ritedose Corporation; Columbia (SC); On-site; USD 60,000 - 80,000; Full time

Job summary

The Ritedose Corporation in Columbia, SC is seeking a Product Formulation Technician-Suspensions to operate compounding equipment in both the Commercial and Development formulation areas, following approved methods to produce a compliant, scalable process. You will ensure documentation and activities in the compounding area meet applicable regulations.

Responsibilities include setting up and validating equipment, performing in-process testing, maintaining logbooks, and supporting new formulation

Qualifications

• 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

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.

Skills

Training completion COMP 1

Training completion DISP1

Training completion BUD

Training completion BUD-V

Training completion Isolator

Training completion Cyclo

Training completion Small Scale Equip

Training completion Lab Equip

Education

High School diploma or GED

Job description

The Ritedose Corporation in Columbia, SC is seeking a Product Formulation Technician-Suspensions to operate compounding equipment in both the Commercial and Development formulation areas, following approved methods to produce a compliant, scalable process. You will ensure documentation and activities in the compounding area meet applicable regulations.

Responsibilities include setting up and validating equipment, performing in-process testing, maintaining logbooks, and supporting new formulation