Quality Analytics Specialist

Primary Responsibilities

• Manage the KPI application and database and generate and distribute monthly reports
• Manage the QUINTET application and database and generate and distribute monthly reports
• Generate compliance metrics based on external inspection and internal audit data
• Work with other departments on periodic updates of existing and potential metric and KPI parameters
• Generate various reports on periodic basis for distribution within Biomat USA and other Grifols entities
• Aid in the development of additional mechanisms for assessing data and quality analytics within the organization
• Support the improvement of analytic development lifecycle as solutions and applications are developed and implemented
• Continuously assess existing systems, applications and databases for improvements. Work with other departments on periodic updates
• Aid in additional quality monitoring initiatives (i.e. Risk Assessment, Data Integrity, Corporate Deviation Management), when applicable.
• Aid in the development and ongoing updates of cGMP operating procedures that relate to Quality analytics and associated functions

Education & Experience

• Bachelor's degree
• Typically requires 1-2 years of quality systems and data analysis experience in a cGMP and/or IT environment
• Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures
• Excellent quantitative and analytical skills
• Excellent oral and written communication skills
• Strong critical thinking and problem solving skills
• Ability to identify errors and provide corrective action
• Ability to work with others in a team environment
• Knowledge of Microsoft Office applications and computer applications used in the Donor Centers

Occupational Demands

• Work is performed in an office and a laboratory/manufacturing environment
• Exposure to biological fluids with potential exposure to infectious organisms
• Exposed to occasional extreme cold below 32* and high levels of noise in production areas
• Exposure to electrical office and laboratory equipment
• Personal protective equipment required such as protective eyewear, garments and gloves
• Frequently sits for 4-6 hours per day
• May stand; bends and twists neck and waist for 2-4 hours per day
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
• Able to make precise coordinated movements, of the fingers to grasp and manipulate objects
• Occasionally walks
• Repetitive foot movements
• Light to moderate lifting and carrying objects with a maximum lift of 50lbs
• Near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye
• Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences