Senior Analytical Chemistry Laboratory Consultant

Senior Analytical Chemistry Laboratory Consultant

VTI Life Sciences is seeking an experienced Senior Analytical Chemistry Laboratory Consultant to perform a comprehensive assessment of an in-house Quality Control chemistry laboratory supporting raw material, in-process, and finished product release testing for multiple manufacturing sites. The consultant will evaluate laboratory operations, analytical methods, procedures, documentation, equipment, computerized systems, and quality controls for compliance with applicable current Good Manufacturing Practice (cGMP) requirements, United States Pharmacopeia (USP) requirements, and recognized pharmaceutical laboratory industry practices.

The successful candidate should have extensive hands-on and/or laboratory leadership experience in a GMP-regulated pharmaceutical Quality Control laboratory and be capable of independently identifying compliance gaps, evaluating analytical practices from both a regulatory and scientific perspective, and recommending practical corrective and improvement actions. We offer an opportunity to support our teams of industry subject-matter experts and thought leaders while consulting with leading companies in the Life Sciences industry.

Location:

Mundelein, IL

Start Date:

September 2026

Employment Classification:
Contract

Length of Project:
Approximately 3 months

90% to 100% On-site.

• Conduct a comprehensive assessment of analytical laboratory operations against applicable FDA cGMP requirements, USP requirements, internal procedures, and recognized pharmaceutical industry practices.
• Evaluate laboratory organization, staffing, training, analyst qualification, supervision, and Quality Unit oversight.
• Review laboratory practices associated with raw material, in-process, and finished product release testing, including sample receipt, handling, storage, testing, review, retention, and disposition.
• Assess the execution and control of compendial and non-compendial analytical methods.
• Evaluate laboratory practices involving analytical techniques and equipment such as HPLC/UPLC, GC, UV-Vis, FTIR, TOC, pH, conductivity, Karl Fischer, titration, dissolution, and other applicable chemical and physical testing.
• Assess analytical method validation, verification, transfer, and method suitability practices, including evaluation of accuracy, precision, specificity, linearity, range, robustness, detection/quantitation limits, and other applicable method characteristics.
• Review laboratory controls for standards, reference materials, reagents, solutions, columns, and other laboratory supplies, including preparation, qualification, labeling, storage, expiration/retest dating, and traceability.
• Evaluate analytical equipment qualification, calibration, preventive maintenance, system suitability, and routine performance controls.
• Assess chromatographic data systems and other laboratory computerized systems from a laboratory-user and data-integrity perspective, including user access, audit trails, electronic records, data review, and retention practices.
• Review laboratory data integrity and Good Documentation Practices, including raw data, worksheets, laboratory notebooks, calculations, electronic records, metadata, data review, and record retention.
• Evaluate procedures and practices for handling OOS, OOT, atypical results, invalid tests, deviations, laboratory errors, retesting, resampling, and investigations.
• Assess laboratory investigation practices to determine whether investigations are scientifically sound, adequately documented, identify appropriate root causes, and result in effective CAPA where required.
• Evaluate laboratory trending and statistical review practices for analytical results, OOS/OOT events, method performance, and other relevant quality indicators.
• Review laboratory controls associated with specifications, Certificates of Analysis, test-result approval, and release decisions.
• Assess laboratory facility conditions and workflow, including sample and standard storage, environmental controls where required, segregation of activities, and controls designed to prevent sample mix-ups or contamination.
• Review the adequacy of SOPs, specifications, analytical methods, protocols, worksheets, and other controlled laboratory documentation.
• Evaluate the interface between the laboratory and the manufacturing sites it supports, including sample submission, specifications, methods, investigations, data communication, change control, and responsibilities for product disposition.
• Assess change-control practices associated with analytical methods, specifications, equipment, computerized systems, and laboratory procedures.
• Identify compliance gaps, operational weaknesses, and opportunities for improvement and prioritize findings based on potential impact to product quality, data integrity, and regulatory compliance.
• Develop practical, risk-based recommendations for remediation and laboratory improvement.
• Prepare and/or contribute to an assessment report summarizing…