Senior Quality Systems Specialist – Product Reviews & KPIs

Boehringer Ingelheim; Saint Joseph (MO); Vor Ort; USD 100.000 - 140.000; Vollzeit

Benefits dieser Stelle

Zusammenfassung

Boehringer Ingelheim in Missouri is seeking a contract role (12 months) to prepare and manage the annual product reviews quality system and data trend analyses. You will also manage product quality complaints and logistic deviations and oversee CAPA plans.

You will lead investigations, ensure regulatory compliance, and develop KPIs for site management, contributing to our global quality objectives and ongoing improvement initiatives.

Qualifikationen

• Bachelor's degree with 8+ years of GxP experience in a regulated environment.
• Strong understanding of regulatory and cGMP requirements.
• In-depth ability to perform root cause analysis and technical writing.
• Experience developing data trend analysis and KPIs for QA processes.

Aufgaben

• Independently prepares annual product reviews and data trend analysis.
• Assist with audits to ensure regulatory compliance and quality requirements.
• Lead projects aligned with corporate priorities.
• Track and complete product quality complaints and logistic deviations in the system.
• Manage the quality system for annual reviews, complaints, and deviations.
• Develop and maintain KPIs and monthly reporting; drive process improvement.

Kenntnisse

GxP experience

Regulatory compliance

Root cause analysis

Technical writing

Data trend analysis

Quality systems

Ausbildung

Bachelor's degree in a relevant scientific field

Jobbeschreibung

Boehringer Ingelheim in Missouri is seeking a contract role (12 months) to prepare and manage the annual product reviews quality system and data trend analyses. You will also manage product quality complaints and logistic deviations and oversee CAPA plans.

You will lead investigations, ensure regulatory compliance, and develop KPIs for site management, contributing to our global quality objectives and ongoing improvement initiatives.