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Statistical Process Control Specialist

2 months ago

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Job Title: Statistical Process Control Specialist

The Statistical Process Control Specialist is a critical role within American Regent, Inc. responsible for developing, implementing, and overseeing a statistical process control (SPC) program within our aseptic manufacturing process.

Key Responsibilities:
  • Develop and implement a comprehensive SPC program tailored to the specific needs of our aseptic manufacturing process.
  • 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.
  • Collect, analyze, and interpret process data to identify trends, variability, and areas for improvement.
  • Prepare clear and concise reports, including statistical summaries and performance metrics, for management and regulatory purposes.
  • Lead initiatives to improve process capability, reduce variability, and enhance overall efficiency using statistical methods and SPC tools.
  • Implement corrective and preventive actions (CAPAs) based on data analysis findings to address root causes of deviations or non-conformances.
  • Provide training and guidance to personnel involved in data collection and SPC activities to ensure understanding and adherence to SPC principles and procedures.
  • Ensure compliance with cGMP (current Good Manufacturing Practices) and other regulatory requirements related to SPC and quality management systems.
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 or other business 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.
Physical Environment and Requirements:
  • Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves.
  • Employee must be able to occasionally lift and/or move up to 15 pounds.

American Regent, Inc. offers a competitive total rewards package, including healthcare, life insurance, profit sharing, paid time off, matching 401k, and a wide range of other benefits. We celebrate diversity and are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.