Quality Systems Specialist – Product Reviews & Complaints

our future employee; Saint Joseph (MO); On-site; USD 90,000 - 120,000; Full time

Job summary

Boehringer Ingelheim is seeking a Principal Specialist, Quality Systems, Product Summary Reports to manage annual product reviews and related data analysis. The role also handles product quality complaints, investigations of deviations, and KPI reporting to site management.

The position requires a Bachelor's degree in a scientific field and 8+ years of GxP experience, with strong regulatory knowledge and cGMPs.

Qualifications

• Bachelor's degree in a relevant scientific field with 8+ years of GxP experience.
• Work experience in a regulated GxP industry is required.
• Deep understanding of regulatory and corporate requirements, cGMPs, technical writing and root cause analysis.

Responsibilities

• Independently prepares annual product reviews and data trend analysis.
• Assist with audits to ensure compliance with regulations and guidance documents.
• Lead projects and align priorities with corporate and functional goals.
• Track and complete product quality complaints and logistic deviations in the electronic system.
• Manage the quality system for annual product reviews, product quality complaints, and logistic deviations.
• Develop and maintain KPIs and monthly reports; lead continuous process improvements.

Skills

GxP experience

Regulatory knowledge

cGMPs

Technical writing

Root cause analysis

Education

Bachelor's degree in science

Job description

Boehringer Ingelheim is seeking a Principal Specialist, Quality Systems, Product Summary Reports to manage annual product reviews and related data analysis. The role also handles product quality complaints, investigations of deviations, and KPI reporting to site management.

The position requires a Bachelor's degree in a scientific field and 8+ years of GxP experience, with strong regulatory knowledge and cGMPs.