Statistical Process Improvement Manager
1 week ago
About the Role
We are seeking a highly skilled Statistical Process Improvement Manager to join our team at American Regent Laboratories.
Job Summary
In this role, you will be responsible for leading efforts to update and optimize our statistical process control (SPC) program while developing and expanding SPC to improve organizational outcomes.
Key Responsibilities
- Develop and implement a comprehensive SPC program tailored to our specific needs.
- Collaborate with cross-functional and cross-site teams to ensure alignment of SPC practices with company goals and regulatory standards.
- Manage and optimize the existing control chart program within the Inspection Department.
- Analyze and interpret process data to identify trends, variability, and areas for improvement.
- Prepare clear and concise reports, including statistical summaries and performance metrics.
- Lead initiatives to improve process capability, reduce variability, and enhance overall efficiency using statistical methods and SPC tools.
- Implement corrective and preventive actions based on data analysis findings.
- Provide training and guidance to personnel involved in data collection and SPC activities.
Requirements
- Bachelor's degree in Statistics, Engineering, Chemistry, Pharmacy, or related field required; Master's degree preferred.
- Minimum of 3-5 years of experience in implementing and overseeing statistical evaluation programs within a pharmaceutical manufacturing environment.
- Proficiency in statistical software and Microsoft Office Suite.
- Strong understanding of statistical principles, control charting techniques, and data analysis methodologies.
- Experience with regulatory requirements (FDA, EMA, etc.) and quality management systems (ISO, cGMP).
- Excellent communication skills, both verbal and written, with the ability to effectively interact with cross-functional teams and senior management.
About Us
American Regent Laboratories celebrates diversity and is committed to creating an inclusive environment for all employees. We offer a competitive total rewards package, including healthcare, life insurance, profit sharing, paid time off, matching 401k, and more.
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