Position Description, Functions, Duties and Tasks:
The Technician serves as a resource for the method execution to support the release of Raw Materials, In Process samples, Active Pharmaceutical Ingredients, and Finished Products. The Technician will own the testing and associated data related to Certificate of Testing. The Technician will be knowledgeable of laboratory operations and execute methods per standard operations procedures and escalate any issues to the Chemist.
Functions, Duties, Tasks:
· Assists Chemists in the update of quality systems for analytical testing.
· Provides technical support for continuous improvement in operations by involvement in SOPs and change control systems.
· Assists in the continued training and development of all team members in the areas of safety, cGMP compliance, and on-the-job requirements.
· Reviews and approves SOPs and analytical data.
· Assesses any out-of-specification (OOS) results, determines impact on product, and ensures timely resolution or corrective action, as needed.
· Prepares systems trends utilizing statistical process control.
· Participates in quality audits as needed.
· Performs the following procedures: HPLC, SDS Page, UV, Dissolution Testing, Viscometry, Particle Size, KF, AA, and etc., as needed.
· Perform Wet Chemistry testing.
· Effectively interfaces and communicates with manufacturing personnel to ensure that the analytical needs of the manufacturing facility and operations are met.
· Follows appropriate protocols, SOPs, compendial and analytical methods, and stability protocols for sampling and testing raw materials, bulk powder and finished product.
· Performs basic diagnostic and troubleshooting procedures for laboratory equipment, as needed.
· Performs basic diagnostic and troubleshooting procedures for test methods.
· Prepares controls, standards, solutions, samples, and maintains proper documentation as required by the QC laboratory.
· Assist with receiving samples into QC.
· Prepare samples for testing and shipping to external laboratory.
· May write and revise supporting SOP’s and specifications.
· Maintains appropriate equipment, records, files, and logs according to SOPs and appropriate regulatory requirements.
· Assists in the maintenance of laboratory requirements, including reagents and supplies.
· Performs all activities in a safe and conscientious manner. Maintains a clean environment and assists with periodic lab clean-ups, and moving of equipment and laboratory supplies.
· Data entry into applicable database
· Able to handle change productively and handle other tasks as assigned.
Union Agener Animal Health, located in the city of Augusta, Georgia, United States, is a biotechnology unit dedicated to animal health.
The plant was acquired in October 2018 by Fernando de Castro Marques, a majority shareholder of União Química, one of the largest groups in the pharmaceutical industry in Brazil. “Now we are in full control of operations and we will begin production of new Posilac® batches to fully satisfy the demands of the American market and other export markets,” says Fernando de Castro Marques, president of Union Agener and Grupo União Química Farmacêutica.
The unit has state-of-the-art technology and produces, on a large scale, Posilac® product (rbST – recombinant bovine somatotropin), used to increase milk production. The plant has 129,000 m² of total area, of which 24,000 m² is built, with a high-tech vertical production. The product is marketed globally under the trademarks Posilac® and Lactotropin.
This factory complex is FDA certified, having the product present in 22 countries, including the USA.