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Associate Scientist - Denton, TX
For this candidate we are looking for individuals with strong stability experience and previous analytical experience to support production testing. We ask that the applicant is flexible as training will be a minimum of 3 months on first shift prior. Once training is complete, the applicant will transition to second shift weekends. Please see below for requisition details.
• Training Schedule will be Monday to Friday (9am – 5:30pm)
• Normal shift will be Thursday to Saturday (12noon – 12:30am) following training
• Weekend coverage as needed
The job purpose is the analyze both chemical and physical testing of raw materials, bulk, and finished goods, provides quality disposition of the analysis, coordinates out of specification investigation, implements corrective actions for investigations, method transfer, suggests and implements continuous improvements. Works with the lab team to achieve efficient functioning of the quality control analytical laboratory. Understands FDA and current Good Manufacturing Practices.
Skillsets for the Scientist position.
• Ability to troubleshoot & operate an HPLC (High Performance Liquid Chromatography)
• Experience operating a GC (Gas Chromatography)
• Understands GLP (Good Laboratory Practices)
1. Under general guidance, independently performs analytical tests utilizing chromatography, spectroscopy, wet chemical analysis, and other known tests according to Good Laboratory Practices (GLP) on raw materials, bulk, and finished goods manufactured for release to the market. Assists Processing with batch color corrections, if needed.
2. Documents test results and makes decision for product acceptance and rejection based on the results to the product specification and releases the product within the Laboratory Information Management System, LIMS.
3. Manages the daily lab priorities alongside other scientists by assisting them in good laboratory techniques, practices, and procedures. 80%
4. Manage raw material program and OTC Annual Product Review by analyzing the data and recommending changes as needed to leadership.
5. Responsible for the IQOQPQ, calibration, and maintenance of laboratory equipment to ensure compliance with FDA regulations.
6. Interfaces with other cross functional teams within Quality, Product Integrity, Process Development, and Manufacturing to obtain samples, discuss test results, gather information, increase understanding of quality testing, and make recommendations as appropriate.
7. Lead lab investigations for out of specification results and implements corrective and preventative actions.
8. Coordinates, trains, and executes method transfer with R&D. 10%
9. Suggest and implement continuous improvement projects and best practices to improve the overall working environment of the lab. 10%
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.