Quality Assurance Process Control Specialist

7 days ago


Shirley, New York, United States American Regent, Inc. Full time
Overview

American Regent, Inc. is a leading manufacturer of pharmaceutical products, and we are seeking an experienced Statistical Process Control Specialist to join our team.

Salary & Benefits

The estimated salary for this role is between $78,100 - $85,000 per year. In addition to the competitive salary, we offer a comprehensive total rewards package that includes healthcare, life insurance, profit sharing, paid time off, matching 401k, and other benefits.

Job Description

The Statistical Process Control Specialist will be responsible for developing, implementing, and overseeing a statistical process control (SPC) program within our aseptic manufacturing process. This individual will lead efforts to update and optimize our existing control chart program while developing and expanding SPC to improve organizational outcomes.

The successful candidate will ensure that our manufacturing processes meet quality standards, regulatory requirements, and operational efficiency goals through effective data analysis and continuous improvement initiatives. Key responsibilities include:

  • Developing and implementing a comprehensive SPC program tailored to the specific needs of our aseptic manufacturing process
  • Collaborating with cross-functional and cross-site teams to ensure alignment of SPC practices with company goals and regulatory standards
  • Managing and optimizing our existing control chart program within the Inspection Department
Required Skills & Qualifications

To perform this job successfully, the ideal candidate will have a Bachelor's degree in Statistics, Engineering, Chemistry, Pharmacy, or a related field, and at least 3-5 years of experience in implementing and overseeing statistical evaluation programs within a pharmaceutical manufacturing environment or other business environment.

The successful candidate will also possess strong understanding of statistical principles, control charting techniques, and data analysis methodologies. Additionally, they will have proficiency in statistical software and Microsoft Office Suite, as well as excellent communication skills and ability to effectively interact with cross-functional teams and senior management.

Work Environment

This position requires the ability to work in a cleanroom/protective gowning environment and occasionally lift up to 15 pounds. We celebrate diversity and are committed to creating an inclusive environment for all employees. American Regent, Inc. is 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.



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