Christopher Haefner Email & Phone Number

Bethlehem, Pa, Us

Collaborated with cross functional teams including Quality Assurance, Quality Control, Operations, Process Engineering, Project Management, and R&D to significantly reduce nonconformances in the medical device industry. Responsible for establishing quality standards, authoring product impact assessments, and leading root cause investigations. Successfully implemented corrective and preventative actions which focused on streamlining operational efficiencies, increasing right first time manufacturing, and driving overall bottom line profits.

Engineering team member responsible for leading pharmaceutical manufacturing investigations and process improvement projects on cross-functional teams. Applied root cause analysis for reporting process deviations using a diverse perspective including safety, compliance, equipment, processes, and people. Provided support for operations through the implementation of corrective actions, change controls, and technical documentation updates.

Bethlehem, Pennsylvania, Us

Ensuring the timely and accurate manufacture of medical devices through appropriate scheduling of daily activities. Focused on GMP adherence through on-line inspections and cross training operators on all processes. Participant in non-conformance reporting, CAPA requirements, and inventory management.

Bethlehem, Pennsylvania, Us

Development and delivery of lateral flow assay card components for infectious disease product lines. Collaborated with cross-functional teams for continuous process improvement of automated and semi-automated equipment.

Bethlehem, Pennsylvania, Us

Responsible for implementing validation protocols, nonconformance investigations, and planned deviation reports to accurately identify process improvement paths within manufacturing. Facilitated information through a cross-functional team including quality assurance, finance, regulatory, research and development, and engineering.

St Louis, Mo, Us

Bachelor Of Applied Science - Basc, Technical Leadership

Associate Of Science - As, Biology/Biological Sciences, General