Statistical Process Control Specialist

Nature and Scope

The Statistical Process Control Specialist is responsible for developing, implementing and overseeing a statistical process control (SPC) program within an aseptic manufacturing process. This role is integrated with the Inspection Department, where an existing control chart program exists, and the Specialist will lead efforts to update and optimize this process while developing and expanding SPC to improve organizational outcomes. The position ensures that manufacturing processes meet quality standards, regulatory requirements, and operational efficiency goals through effective data analysis and continuous improvement initiatives.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

Implementation of Statistical Process Control (SPC) Program:

• Develop and implement a comprehensive SPC program tailored to the specific needs of the aseptic manufacturing process.

• Collaborate with cross-functional and cross-site teams including Quality Assurance, Manufacturing, Engineering, and Validation to ensure alignment of SPC practices with company goals and regulatory standards.

Overseeing and Updating Control Chart Program:

• Manage and optimize the existing control chart program within the Inspection Department.

• Ensure control charts accurately reflect process performance and support timely decision-making to maintain product quality and compliance.

Data Analysis and Reporting:

• 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.

Continuous Improvement Initiatives:

• 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.

Training and Knowledge Sharing:

• Provide training and guidance to personnel involved in data collection and SPC activities to ensure understanding and adherence to SPC principles and procedures.

• Foster a culture of data-driven decision-making and quality excellence throughout the organization.

Regulatory Compliance and Quality Assurance:

• Ensure compliance with cGMP (current Good Manufacturing Practices) and other regulatory requirements related to SPC and quality management systems.

• Support regulatory inspections and audits by preparing documentation and facilitating discussions related to SPC practices.

• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Bachelor's degree in Statistics, Engineering, Chemistry, Pharmacy, or related field required; Master's degree preferred. Candidates with equivalent years of experience will be considered.

• Minimum of 3-5 years of experience in implementing and overseeing statistical evaluation programs 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. PPE is essential for the health and safety of employees.

• Employee must be able to occasionally lift and/or move up to 15 pounds.

Expected Salary Range:

$78,100 - $85,000

The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.

American Regent celebrates diversity and we 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.

American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.