Quality Analyst I
4401 Freidrich Lane, USAUS Austin, TX 12345 US
- Under direct supervision, support the quality system by collecting, analyzing, and disseminating performance data used for quality control monitoring, root cause analysis, laboratory performance assessments, and continuous improvement activities.
- Collect quality related performance data from production and laboratory support activities.
- Perform standard data reduction techniques to assess data, and provide weekly and monthly reports to laboratory management.
- Assist laboratory management in gathering, compiling, and analyzing data for investigations, studies, or other special projects.
- Write simple error investigation reports, including determining remedial actions, analyzing and determining error risk and impact, analyzing and determining root cause, and proposing corrective and preventative actions.
- Work on problems of moderate scope where analysis and situations of data requires a review of a variety of factors.
- Conduct investigation meetings of applicable laboratory staff members to apply quality analytical tools to determine root cause of laboratory errors and proposed corrective and preventative actions.
- Communicate performance data with laboratory internal and external customers.
- Assist in internal and external audits.
- Accurately complete detailed documentation as required by established procedures and good documentation practices regulations.
- Effectively communicate with personnel from various departments building productive internal/external working relationships, and escalate issues and identified quality related performance data trends to Quality Management.
- A intermediate level of understanding of Microsoft Excel required, including writing basic formulae to extract, reduce, analyze, format, and graph large groups of data.
- Light statistical analysis background necessary such as population distribution, regression analysis, confidence intervals, linearity, outlier detection, and quality control charting.
- Knowledge of Microsoft PowerPoint also required.
- Knowledge of CAPA system and root cause investigation tools preferred.
- Requires a minimum of 1 year of practical experience working as a quality assurance professional in a cGMP regulated environment.
- Able to communicate complex information and ideas so others will understand.
- Ability to listen to and understand information and ideas presented through spoken words and sentences.
- Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.
- Frequently interacts with others, relates sensitive information to diverse groups.
- Must work with diverse groups to obtain consensus on issues.
- Ability to apply abstract principles to solve complex conceptual issues.
- Work is performed in an office environment with exposure to electrical office equipment.
- Frequently sits for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Occasionally walks.
- Occasionally bends and twists neck.
- Light to moderate lifting and carrying objects with a maximum lift of 25lbs.
- Frequently drives to site locations with occasional travel within the United States.
Bachelor degree required. Science, mathematics, or quality related field preferred.