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QC Laboratory Systems Improvement Specialist

Guerbet -
Raleigh, NC

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Job Details

Full-time

Qualifications

Data integrity assurance
Continuous improvement (laboratory quality control method)
Data quality management
Pharmaceutical company experience
Pharmaceutical analysis
Quality control experience within pharmaceutical industry
GMP for research safety and compliance

Full Job Description

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients.

Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging.

WHAT WE ARE LOOKING FOR

The QC Laboratory Systems Improvement Specialist operates in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.

This role focuses on improving QC laboratory quality systems within a GMP pharmaceutical environment by turning regulatory requirements and internal findings into practical, sustainable solutions. It works closely with QC teams and leadership to enhance compliance, data integrity, and overall laboratory practices. The position is hands-on and collaborative, emphasizing implementation of improvements rather than oversight, and requires strong scientific knowledge and a pragmatic approach to strengthening laboratory operations. THIS ROLE IS A CONTRACT ROLE FOR 18-24 MONTHS AND WILL BE ELIGIBLE FOR GUERBET BENEFITS

YOUR ROLE

Drive implementation of CAPAs and QC quality system improvements from audits and assessments, translating regulatory requirements into actionable laboratory practices.
Partner with QC teams to embed sustainable corrective and preventive actions, track progress, remove barriers, and verify effectiveness through data-driven follow-up.
Enhance SOPs, workflows, and procedural controls by developing practical, GMP-compliant processes that reinforce adherence to data integrity principles (ALCOA+).
Improve lifecycle management of analytical methods and strengthen equipment qualification practices (IQ/OQ/PQ), ensuring instruments meet audit trail, system control, and data integrity requirements.
Strengthen OOS/OOT investigation processes by improving root cause analysis and ensuring alignment with FDA and global regulatory expectations.
Enhance processes for reference standards, reagents, and sample management, ensuring proper qualification, traceability, and lifecycle control of laboratory materials.
Support improvements to stability programs, including protocols, scheduling, and data evaluation, ensuring alignment with ICH Q1 and global regulatory requirements.
Performs other duties as assigned by management

YOUR BACKGROUND

Required Qualifications

10+ years of experience in Quality Control, Analytical Chemistry, or Microbiology within a GMP pharmaceutical environment.
Demonstrated experience contributing to laboratory quality system improvements or remediation initiatives in regulated pharmaceutical environments.
Strong understanding of regulatory expectations related to data integrity, laboratory investigations (OOS/OOT), and analytical controls.
Expertise in chromatographic techniques (HPLC, UPLC, GC) and/or microbiological laboratory testing.

Preferred Qualifications

Advanced knowledge of microbiological testing, including sterility testing (USP <71>), endotoxin testing (USP <85>), bioburden, and sterilization/dehydrogenation principles.
Familiarity with global microbiological regulatory standards (USP, EP, JP).
Understanding of Annex 1 environmental monitoring expectations, including contamination control strategies and trending methodologies.

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