QC Laboratory Systems Improvement Specialist

Laboratoire Guerbet•Raleigh, IL

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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