Quality Assurance Specialist

Linde•Bethlehem, PA

8d•Onsite

About The Position

This role provides regulatory and quality systems support aligned with FDA and Good Manufacturing Practice standards across multiple locations. It involves leading training initiatives for managers, supervisors, and personnel on company and regulatory procedures. The specialist will conduct audits and assessments of manufacturing sites, warehouses, and vendors to ensure compliance with quality and regulatory requirements. A key part of the role is delivering detailed assessment reports and facilitating review meetings to communicate findings and improvement opportunities. The position also involves promoting active participation in local quality meetings, fostering a culture of continuous quality improvement, and serving as a compliance advisor to regional Quality Assurance leadership, supporting program development and implementation. Additionally, the role assists in investigating and managing customer complaints and internal nonconformances to drive resolution and corrective actions, and performs additional duties as needed to support quality assurance objectives and organizational goals.

Requirements

Bachelor’s or Associate Degree in Science, Engineering, or a related technical field.
5 or more years of experience in Quality Assurance or quality management roles.
Strong communication skills and organizational agility to manage multiple priorities effectively.
Solid skills in spreadsheet and database management for data analysis and reporting.
Working knowledge of ISO 9001 standards and quality management system principles.
Understand packaged gas production operations, process controls, and analytical methods.
Able to engage in extended periods of sitting, talking, and hearing with occasional standing and walking.
Capable of lifting or moving up to 20 pounds as required.
Willing to travel up to 50% to support multiple locations and initiatives.

Responsibilities

Provide regulatory and quality systems support aligned with FDA and Good Manufacturing Practice standards across multiple locations.
Lead training initiatives for managers, supervisors, and personnel on company and regulatory procedures.
Conduct audits and assessments of manufacturing sites, warehouses, and vendors to ensure compliance with quality and regulatory requirements.
Deliver detailed assessment reports and facilitate review meetings to communicate findings and improvement opportunities.
Promote active participation in local quality meetings and foster a culture of continuous quality improvement.
Serve as a compliance advisor to regional Quality Assurance leadership, supporting program development and implementation.
Assist in investigating and managing customer complaints and internal nonconformances to drive resolution and corrective actions.
Perform additional duties as needed to support quality assurance objectives and organizational goals.