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Form of workThe Performance Analyst extracts and compiles data from various Kankakee Quality Systems on a weekly, monthly, and annual basis in support of Process and Quality metrics analysis and reporting. The role transforms exported data into graphical charts for use by Senior Management and for presentation to auditors during regulatory inspections. This position provides data as requested to Kankakee Manufacturing, Quality, and Production Support departments as required for investigations and departmental performance tracking.
Responsibilities:
- Maintains Quality Site metrics, keeping them up to date and published, including continuous process monitoring.
- Compiles data on a routine basis and prepares information for the Kankakee site Quality Management Review (QMR), as well as aligning the process globally for executive-level review. Provides information in preparation for the Quarterly QMR.
- Routine reporting of metrics and data, including data for the Annual Product Quality Reviews.
- Publishes pre-reads of QMR presentations prior to meetings, records meeting minutes for each QMR, and publishes them following meetings.
- Maintains the Quality Site Metrics, minimally on a weekly basis through the weekly Quality eBulletin.
- Provides data as requested to support any monthly reports for operations/quality.
- Assists the Quality Systems Manager with Annual Product Quality Review (APQR) report generation for all Kankakee products.
- Serves as assistant to, and back-up for, Quality Systems Manager in all matters pertaining to monthly QO-311 data reporting, APQR/CV generation, and report approval routing in the DMS.
- Explores improvements to current data extraction and reporting methods based on new enterprise and quality system implementation such as PACE, QlikView dashboards, statistical analysis software and updates to StarLIMS, TrackWise and docNet.
Qualifications:
- B.A. or B.S. degree, preferably in a scientific, statistical or technical field (e.g., Chemistry, Biology, Engineering, Computer Science or Statistics)
- Minimum 2 years’ experience working in a cGMP regulated environment such as the fields of Pharmaceutical, Quality, Manufacturing or Engineering.
- Knowledge of FDA guidelines required.
- Proficient in the Microsoft Office suite, including advanced Excel preferred.
- Statistical background a strong plus.
- Experience in TrackWise, SAP, STARLIMS, Power Bi, and Veeva preferred.
- Demonstrated competency of verbal and written communication.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
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