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.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.