QC Analytical Instrument & Method Validation Consultant

Role: QC Analytical Instrument & Method Validation Consultant

Location: Lexington, MA – Boston Area

Job Description

We are seeking an experienced QC Analytical Instrument & Method Validation Consultant to support a laboratory transformation and analytical instrumentation program within a GMP-regulated life sciences facility in Lexington, MA.The consultant will support the implementation and qualification of four new titrators, one density meter, and upgrades to three existing UV/UV-Vis spectrophotometers. This role requires hands-on experience in laboratory execution, instrument qualification, analytical method validation/transfer, controlled documentation, and QC analyst training.Key ResponsibilitiesSupport feasibility studies and laboratory experiments for new and upgraded analytical instruments.Execute IQ/OQ/PQ and other instrument qualification activities according to approved protocols.Support qualification and implementation of:TitratorsDensity metersUV/UV-Vis spectrophotometersAuthor, revise, execute, and close laboratory and instrument SOPs.Author and revise analytical method procedures and supporting documentation.Execute analytical method validation, verification, transfer, and implementation activities.Build analytical methods and perform assay execution on laboratory instruments.Establish and document method suitability, acceptance criteria, deviations, data review, and report closure.Support analytical method transfers to new instruments while maintaining comparability, traceability, and data integrity.Prepare and maintain qualification, validation, method, and laboratory documentation in compliance with GMP/GxP requirements.Train QC analysts on instrument operation, analytical methods, assay execution, and laboratory workflows.Collaborate with QC, QA, Training, IT, Capital Project Management, Analytical Instrument Qualification, and other site stakeholders.Maintain project trackers and ensure documentation and project deliverables are completed within established timelines.Support instrument replacement, commissioning, remediation, and laboratory transformation activities.Identify, document, investigate, and follow up on deviations as required.Work independently with limited direction while effectively communicating project status, risks, and deliverables.Required QualificationsBachelor’s degree in Chemistry, Biochemistry, Biology, or a related scientific discipline.Approximately 4+ years of relevant laboratory experience, preferably within a GMP QC environment.Hands-on experience with instrument qualification, including IQ/OQ/PQ.Experience with analytical method transfer, validation, verification, or implementation.Experience authoring, revising, executing, or closing:SOPsAnalytical methodsQualification protocolsValidation protocolsTechnical reportsStrong understanding of GMP/GxP documentation, data integrity, traceability, deviations, and controlled document workflows.Strong written and verbal communication skills.Ability to collaborate effectively with cross-functional QC, QA, Validation, IT, Training, and Project Management teams.Ability and willingness to work fully onsite in Lexington, MA approximately 40 hours per week.Must be available to support project start dates and key milestone windows.