Job Summary

The Quality Intern will work quality business unit to extrapolate data from various sources, analyze the data, and format it into a presentable report for the Annual Product Quality Review.

Area Of Responsibility

• Extract information from product Batch Records (paper/electronic) ad develop tabular information electronically to support Annual Product Quality Review (APQR) Report under supervision
• Consolidate, trend and develop graphic presentation of drug product manufacturing data and laboratory test results electronically for further review and incorporate in APQRs
• Support Quality Management System (QMS) records to further develop, determine product applicability, trend and present electronically tabulated from under supervision for APQR
• Other duties as assigned

Work Conditions:

• Office

Physical Requirements:

• Operates computer/office machines
• Lift up to 25 lbs.
• Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, hear and talk

Travel Estimate

n/a

Education and Job Qualification

• Strong team player
• Excellent oral and written and interpersonal communication skills
• Completion of at least one year of college study, preferably in science, technology or analytics
• Ability to follow specific instruction (i.e. written SOPs)
• Strong analytical skills with attention to detail

Experience

• Working knowledge of cGMP/GLP is a plus
• Proficient computer skills including Word, Excel (including tables and graphs), PowerPoint, and Adobe
• Work experience, preferably using analytical skills in a quality environment
• Experience using a Quality Management System is preferred