Key Responsibilities:
* Sources and verifies process data from paper records and database systems (LIMS, Qumas, OPM, Historian) to support timely and efficient data monitoring needs.
* Collaborates with cross-functional departments to ensure process data are used for improving process understanding and facilitating continuous improvement opportunities.
* Develops automated solutions addressing specific analytical objectives and facilitates report generation and distribution of analyses.
* Runs quality system events related to data integrity and data management such as investigations, CAPAs, and change controls.
* Applies data visualization tools to translate data into useful information for operations managers and process engineers.
* Analyses data sources and develops strategies and solutions for data acquisition, aggregation, and reporting.
* Provides audit and regulatory submission support where applicable.
This role is ideal for individuals who possess strong communication and interpersonal skills, logical troubleshooting and problem-solving abilities, a proven track record of effective communication with multiple partners, and strong mathematics and statistical skills for complex data analysis.
To be considered for this opportunity, you should have a BS/BA in mathematics/statistics or a related field. Experience in a biopharmaceutical cGMP manufacturing setting is an advantage.