Manufacturing Compliance Expert

3 days ago


St Louis, Missouri, United States Mallinckrodt Full time
About the Job">

Mallinckrodt is seeking an experienced Manufacturing Compliance Expert to join our team at the St. Louis Plant.

About the Role">

This position will be responsible for ensuring compliance with cGMP guidelines and regulations, including ICH Q7, CFR 210, and 211.

Key Responsibilities">
  • ">
  • This role will lead and participate in Root Cause Analysis and Process Improvement Teams, regularly use communication skills to exchange information with other departments.">
  • The successful candidate will develop systems for ensuring cGMP compliance of manufacturing documentation systems, quality of documentation, and remediation of issues.">
  • This position requires strong analytical and problem-solving skills, with a focus on managing customer complaints, exceptions, OOSs, CAPAs, and change controls.">
Requirements">
  • ">
  • Bachelor of Science degree in Chemistry, Chemical Engineering, or related science is required.">
  • Minimum 3-5 years of experience in Quality Assurance/Quality Control in a pharmaceutical manufacturing environment.">
  • Strong understanding of basic statistical principles and regulatory expectations.">
  • Proficient in Metric Stream, BPCS, and TrackWise applications.">
  • Demonstrated expertise in root cause analysis tools.">
Compensation and Benefits">

The estimated salary for this position is $95,000 - $125,000 per year, depending on qualifications and experience.

Mallinckrodt offers a comprehensive benefits package, including health insurance, retirement plan, and paid time off.



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