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Analyzes both chemical and physical testing of raw materials, bulk, finished goods and stability, 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. Responsible for stability protocol initiation and approval, pull schedule adherence, OOS investigation and resolution
- Suggests and implements continuous improvement projects and best practices to improve the overall working environment of the lab. Execute tasks as assigned to improve laboratory efficiency.
- Leads lab investigations for out of specification results and implements corrective and preventative actions. Facilitate collaboration between cross-functional departments to resolve Out of Specification investigations.
- Manages the daily lab priorities alongside other scientists by assisting them in good laboratory techniques, practices, and procedures. Documents receipt of samples and records data on laboratory datasheet and on computer system. Prepares worksheets and paperwork related to release various types of samples and coordinate external testing in conformance with approved study. Prepares records necessary to track “hold” items. Conduct Out of Specification investigations on raw materials, bulk, finished goods and stability samples.
- Manages raw material program and OTC Annual Product Review by analyzing the data and recommending changes as needed to leadership.
- 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, finished goods and stability manufactured for release to the market. Assists Processing with batch color corrections, if needed.
- 3+ years laboratory environment experience or equivalent. Prior work experience in a quality control laboratory is preferred.
- Must have a thorough understanding of FDA regulations and current Good Manufacturing Practices.
- Must have a good understanding of Chemistry and laboratory instrumentation to make sound decisions based on the technical information available.
- Must possess both oral and written communication skills in order to make and present recommendations and information and effectively interact with scientific and non-scientific personnel to convey a scientific perspective.
- Bachelor’s degree in Chemistry.
- Must possess the manual dexterity required to perform tests on materials and manipulate instruments.
- Must understand the relationship between the values and goals of the organization to the quality control function.
- Must have “average discrimination” based on the Farnsworth-Munsell Hue Test in order to visually distinguish colors; must also be able to distinguish fragrances.
Company: Mary Kay Global
Vacancy Type: Full Time
Job Location: Houston, TX, US
Application Deadline: N/A