Manufacturing Compliance Expert
3 days ago
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.">
- ">
- 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.">
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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