Summary:
Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems through the participation in management, analysis and monitoring of quality data and metrics and associated quality systems.
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
- Assist in developing additional mechanisms for assessing data and quality analytics within the organization
- Supports 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
- Assists in additional quality monitoring initiates (i.e. Risk Assessment, Data Integrity, Corporate Deviation Management), when applicable.
- Assists 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:
Occupational Demands Form # 34: 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. Ability 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. Performs tasks by following a set of written or oral instructions/procedures.
