Compliance Associate Lead I

3 days ago


Madison, Wisconsin, United States Catalent Pharma Solutions Full time

Catalent Pharma Solutions is committed to a Patient First culture through excellence in quality and compliance. As a Compliance Associate Lead I, you will be responsible for providing support to cGMP manufacturing operations and ensuring compliance with Standard Operating Procedures, regulatory and client requirements.

The estimated annual salary for this position is $90,000-$120,000 based on national averages and location.

You will facilitate Rapid Response Teams as deviations occur, documenting critical information to determine true root cause. You will also provide timely review of logbooks to ensure data complies with cGMP expectations and assist in tracking/monitoring and providing timely, accurate information regarding status of open investigations.

Additionally, you will participate in initiatives to improve process compliance culture, including ongoing cGMP understanding and application, self-audit and CAPA programs. You will also participate in internal audits and assist in closure of applicable findings.

As a Compliance Associate Lead I, you will actively engage in Inspection Readiness activities and teams, assisting in identifying improvements for safety and providing on-the-floor manufacturing support. You will identify and assist with training issues, instruction problems, or new educational needs regarding specific employees or groups or equipment.

You will assist in writing and revising SOPs when gaps are identified. The ability to work scheduled shift and other off-shift coverage as required is also essential.



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