Quality Analyst I - Mon - Fri 8am -5pm
Quality Analyst I
Summary: 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.
Primary responsibilities for role:
- 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.
- Knowledge, Skills, and Abilities
- 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.
- Education
- Bachelor’s degree required. Science, mathematics, or quality related field preferred.
- Experience
- Typically requires a minimum of 1 year of practical experience working as a quality assurance professional in a cGMP regulated environment.
EEO/Minorities/Females/Disability/Veterans