Quality Assurance Specialist
3 days ago
In this role, you will work as a key member of the quality team at Mallinckrodt Pharmaceuticals, responsible for ensuring the highest standards of quality in our manufacturing operations. You will be based in St. Louis, MO, and will report to the Quality Manager.
Responsibilities:- Investigate and resolve customer complaints, OOSs, CAPAs, Exceptions, and Change Controls.
- Provide technical guidance and support to manufacturing personnel, quality engineers, and quality control labs.
- Develop and maintain systems for ensuring cGMP compliance of manufacturing documentation and quality of documentation.
- Lead and participate in root cause analysis and process improvement teams.
- Perform GMP walkthroughs with production on a routine basis.
- Bachelor's degree in Chemistry, Chemical Engineering, or related science.
- Minimum 3-5 years of experience in Quality Assurance/Quality Control in a pharmaceutical manufacturing environment.
- Excellent communication and leadership skills.
- Understanding of basic statistical principles and regulatory expectations.
The estimated salary for this position is $85,000 - $110,000 per year, depending on experience. This includes a base salary range and potential bonuses.
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