Quality Analytics Specialist

GRIFOLS, S.A.•NC-RTP, CA

15d•Onsite

About The Position

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.

Requirements

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.

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