503B Formulation Specialist at The Ritedose Corporation in Columbia, South Carolina

Job Description:

The Formulation Specialist position is responsible for compounding sterile drug product utilizing aseptic technique. The Formulation Specialist is responsible for the formulation of bulk pharmaceutical product from raw materials into bulk sterilized pharmaceutical product. This position is also responsible for managing formulation inventory and supplies and is expected to maintain a highly organized work area.

Responsibilities:

• Gather, sanitize and inspect raw materials in preparation for batch formulation.


• Prepare formulation tanks for the addition of raw material.


• Complete formulation process and documentation of process.


• Maintains manufacturing records and completes all required documentation in compliance with cGMP, FDA, USP and pharmacy state board regulatory requirements.


• Operate and monitor technical, computerized, formulation equipment, ensuring quality standards are maintained.


• Prepares records and monitors results for pharmaceutical quality assurance testing.


• Assists with other duties as required.

Qualifications:

• Minimum 2 years experience in cGMP compounding or pharmaceutical industry preferred


• Familiarity with, and the ability to follow established Standard Operating Procedures, Master Batch Records, and adhere to cGMP


• Strong attention to detail, good math skills, and knowledge of Metric System


• Must be able to spend a majority of time standing


• Must be able to work well both individually and on a team


• Must be able to lift, push, pull and carry up to 40+ pounds