This individual will be responsible for the successful operation of the Quality Control team in media testing and release area. The successful candidate will be responsible for managing a group of 6-8 team members. This includes, but is not limited to sample testing, documentation and release of in-process and final media batches as well as the coordination of new method development. This person shall oversee the daily operation of the media testing lab, ensure proper performance of instruments.
Duties and Responsibilities
• Manage the testing of raw material and finished media
• Conduct HPLC testing when needed to guarantee the timely release of media
• Interpret HPLC test results and compare against applicable specifications/historical trends
• Work with Manufacturing and Planning areas to ensure media is processed, tested and released in accordance with company delivery requirements
• Partner with Research and Development and Manufacturing areas to ensure adherence to quality related initiatives
• Conduct regular trend analysis of data and report adverse trends and implement corrective actions as needed
• Lead new product commercialization activities for Quality team
• Oversee creation and approval of SOP and WKI documents needed for testing
• Establish fit-for-purpose testing for new and existing media
• Monitor work area for adherence to company safety policies
• Create, monitor and publish adherence to relevant key performance indicators
• Monitor adherence to ISO-9001 guidelines
• Identify LEAN and Continuous Improvement opportunities for respective work area
• Work with external vendors to measure adherence to internal requirements
• Motivate and manage individual development plans for each team member
• Assist in the development and implementation of Quality standards and procedures
• Partner with Quality Assurance team to release material
• Oversee training activities to ensure team is adequately trained
• Develop testing protocols and review data to set specification limits for new materials
• Initiate non-conformance or out of specification reports as needed
• Manage IQ/OQ/PQ for lab instrumentation such as HPLC, LC/MS and GC/MS
• Apply appropriate “5S” principles in work station
• Support and understand yearly departmental goals
• Other job duties as assigned
• Bachelors Degree in Analytical Chemistry, Biology and/or Life Sciences required.
• Requires analytical thinking and presenting ideas
• should have 5 years of experience managing / leading others
• Sound judgement and reasoning
• Extensive knowledge of HPLC and SPE production
• Able to clearly and systmatically write SOP's, Manuals, etc.
• At least 5 years of Experience in Quality Control in GMP environment
* Minimum of 5 years HPLC required.
* Experience with elemental analysis, GC, GC/MS strongly preferred
* Prior GMP, GLP or ISO-9001 training required
* Knowledge of statistical software such as Minitab preferred
Phenomenex - 16 months ago
Phenomenex is a global technology leader committed to developing novel analytical chemistry solutions that solve the separation and...