Quality Assurance Specialist

Supelco•Bellefonte, PA

4d•$62,900 - $94,400•Onsite

About The Position

The Quality Assurance Specialist in Bellefonte, PA ensures that all aspects of product and service meet quality standards. Job duties include: Support the site's quality management system, ISO accreditations, and regulatory compliance by executing internal/external audits, changing controls, validations, document control, and customer complaint investigations. Review completed batch records for compliance and execute the Management of Change (MOC) process for quality-related modifications to documents, equipment, specifications, and methods. Participate in internal and supplier audit programs by issuing post-audit reports, maintaining the customer audit database, and tracking corrective actions through to final effectiveness checks. Monitor and trend critical quality metrics—including pass rates and customer complaints—while directly responding to client inquiries and managing quality-related customer ratings. Write and/or review documentation to ensure compliance to all standards or regulations Coordinate site validation activities and provide strategic oversight to the calibration department to ensure continuous equipment compliance. Engage regularly with production and laboratory personnel to ensure seamless communication of quality services, while leading root cause analyses and risk assessments for process and product investigations. Lead process improvement projects within the document control system to drive operational efficiencies, while continuously updating and optimizing departmental quality metrics. Coordinate the design and execution of quality training programs to support continuous employee development and maintain site-wide regulatory compliance. Maintain the quality actions and look for trends. 5% travel anticipated.

Requirements

Bachelor’s Degree in Chemistry, Biochemistry, or other science fields OR Quality Assurance
2 + years of quality experience
1 + years of experience working on or leading process improvement projects

Nice To Haves

Knowledge of ISO quality management system
Demonstrate exceptional analytical and organizational skills to prioritize complex workflows, master new concepts rapidly, and utilize advanced computer software (MS Excel, Word, and databases) while maintaining strong interpersonal collaboration.

Responsibilities

Support the site's quality management system, ISO accreditations, and regulatory compliance by executing internal/external audits, changing controls, validations, document control, and customer complaint investigations.
Review completed batch records for compliance and execute the Management of Change (MOC) process for quality-related modifications to documents, equipment, specifications, and methods.
Participate in internal and supplier audit programs by issuing post-audit reports, maintaining the customer audit database, and tracking corrective actions through to final effectiveness checks.
Monitor and trend critical quality metrics—including pass rates and customer complaints—while directly responding to client inquiries and managing quality-related customer ratings.
Write and/or review documentation to ensure compliance to all standards or regulations
Coordinate site validation activities and provide strategic oversight to the calibration department to ensure continuous equipment compliance.
Engage regularly with production and laboratory personnel to ensure seamless communication of quality services, while leading root cause analyses and risk assessments for process and product investigations.
Lead process improvement projects within the document control system to drive operational efficiencies, while continuously updating and optimizing departmental quality metrics.
Coordinate the design and execution of quality training programs to support continuous employee development and maintain site-wide regulatory compliance.
Maintain the quality actions and look for trends