STATISTICAL QUALITY ANALYST

Job Summary

Salary Range - $61,000 - 85,000 annually
Position acts as the statistical subject matter expert for the facility. Plans data collection, and analyzes and interprets numerical data from surveys, experiments, studies, and other sources and applies statistical methodology to provide information for scientific research and analysis. The individual will prepare conclusions and present findings based on data summaries.
Prepares, draws, and plots a variety of standard graphic or tabular presentations for use in statistical studies using mathematical and spreadsheet software programs. Gathers, assembles, classifies, and verifies statistics from specified sources; performs descriptive and inferential statistics; writes and tests written formulas; reconciles data for accuracy and completeness and resolves discrepancies. Has knowledge of statistical methods, modeling, and techniques.

Responsibilities

• Maintains the Investigative database for Incident, CAPA and OOS investigations.  Responsible for tracking and trending activities both within KabiTrack, SAP, and from exterior data sources.
• Supports validation projects with fill weight statistical analysis, trend analysis or data collection. May function as a Study Director for qualifications, validations and/or investigative studies.
• Support site right first time and batch release initiatives
• Evaluates Alert and Action Levels for visual inspection, complaint, and fill yields through statistical analysis of production and quality data and updates or maintains associated standard operating procedures.
• Uses appropriate statistical methodologies to perform descriptive and inferential statistics as requested by management; analyses may help support investigations, CAPAs, validation, or Tech Transfer projects
• Collects and analyzes facility event and CAPA reports. Prepares weekly reports for trend analysis of site metrics in support of maintaining facility “scorecard”.
• Creates or revises corporate and site SOPs utilizing Documentum.
• May execute GAP analysis to help ensure evaluation of key areas, in manufacturing and/or Quality are completed to review compliance.
• Performs other duties as directed by management.

Requirements

• Bachelor's Degree in a technical field with a focus in statistical analysis with 3-5 years of related experience OR Master's Degree in a technical field with a focus in statistical analysis with 1-3 years related experience required.
• Advanced computer skills required.
• Familiarity with Minitab, Excel, R, Visual Basic, and Microsoft Office applications preferred.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.