QC Laboratory Systems Improvement Specialist

WHAT WE ARE LOOKING FORThe 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 that will last 18-24 months and will be eligible for Guerbet's benefits, etc. YOUR ROLEDrive implementation of CAPAs and QC quality system improvements from audits and assessments, translating regulatory requirements into actionable laboratory practicesPartner with QC teams to embed sustainable corrective and preventive actions, track progress, remove barriers, and verify effectiveness through data-driven follow-upEnhance 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 requirementsStrengthen OOS/OOT investigation processes by improving root cause analysis and ensuring alignment with FDA and global regulatory expectationsEnhance processes for reference standards, reagents, and sample management, ensuring proper qualification, traceability, and lifecycle control of laboratory materialsSupport improvements to stability programs, including protocols, scheduling, and data evaluation, ensuring alignment with ICH Q1 and global regulatory requirementsPerforms other duties as assigned by managementProvide support during regulatory inspections and internal audits, including preparation of documentation and responsesAssist in training QC staff on updated procedures, data integrity principles, and quality system improvementsParticipate in cross-functional projects related to quality system enhancements or site initiativesYOUR BACKGROUNDRequired Qualifications10+ years of experience in Quality Control, Analytical Chemistry, or Microbiology within a GMP pharmaceutical environmentDemonstrated experience contributing to laboratory quality system improvements or remediation initiatives in regulated pharmaceutical environmentsStrong understanding of regulatory expectations related to data integrity, laboratory investigations (OOS/OOT), and analytical controlsExpertise in chromatographic techniques (HPLC, UPLC, GC) and/or microbiological laboratory testingPreferred QualificationsAdvanced knowledge of microbiological testing, including sterility testing (USP ), endotoxin testing (USP ), bioburden, and sterilization/dehydrogenation principlesFamiliarity with global microbiological regulatory standards (USP, EP,JP)Understanding of Annex 1 environmental monitoring expectations, including contamination control strategies and trending methodologies