Quality - Quality -Data Analyst

DM Analyst

The DM analyst is responsible for evaluating Deviations to identify patterns and trends, monitor trend investigations E2E including CAPAS and EC to eliminate trends, perform analysis of deviation data and summarize information for Annual Product Quality Review and other required reports. Notification to management of identified trends. Must have knowledge and experience with cGMP manufacturing, Quality, and compliance. Must have experience with Deviations, Root Cause Analysis, and CAPAs.

Must have knowledge of data trending and tracking, including use of statistical analysis software a plus. Proficient in Excel data mining and report creation. Ability to use electronic Quality systems such as Infinity. Junior to intermediate ability to interpret results and situations and articulate recommendations for resolution. Knowledge of US and global cGMP requirements. Excellent verbal and written communication skills.

Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision. Work is self-directed. Confident in making decisions for non-routine issues. Able to prepare written communications and communicate problems to management with clarity and accuracy. Able to effectively multi-task. Associate degree or higher required, minimum of three years of experience in the pharmaceutical or related industry.

Equivalent combination of education and experience acceptable. Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.