Senior Analytical Chemistry Laboratory Consultant

We are seeking a Senior Analytical Chemistry Laboratory Consultant to assess a pharmaceutical QC laboratory supporting raw material, in-process, and finished-product testing across multiple manufacturing sites. Assess analytical techniques including HPLC/UPLC, GC, UV-Vis, FTIR, TOC, Karl Fischer, titration, pH, conductivity, and dissolution.

Job Title: Senior Analytical Chemistry Laboratory Consultant

Location: Mundelein, IL (90 100% Onsite)
Employment Type: Contract
Duration: 4 6 Months

Job Summary

We are seeking a Senior Analytical Chemistry Laboratory Consultant to assess a pharmaceutical QC laboratory supporting raw material, in-process, and finished-product testing across multiple manufacturing sites. The consultant will evaluate laboratory operations, analytical methods, equipment, documentation, computerized systems, data integrity, and quality controls against FDA cGMP, USP, and industry standards.

Responsibilities

Assess QC laboratory operations, procedures, documentation, and compliance with FDA cGMP and USP requirements.

Evaluate raw material, in-process, and finished-product testing processes and analytical methods.

Assess analytical techniques including HPLC/UPLC, GC, UV-Vis, FTIR, TOC, Karl Fischer, titration, pH, conductivity, and dissolution.

Review analytical method validation, verification, transfer, suitability, and troubleshooting.

Evaluate equipment qualification, calibration, preventive maintenance, and system suitability.

Assess chromatography data systems, electronic records, audit trails, access controls, and laboratory data integrity.

Review OOS/OOT investigations, deviations, CAPA, root-cause investigations, and laboratory trends.

Evaluate SOPs, specifications, protocols, worksheets, and controlled documentation.

Identify compliance gaps and develop risk-based remediation and laboratory improvement recommendations.

Prepare assessment reports and present findings to Quality, laboratory management, Manufacturing, and senior stakeholders.

Required Qualifications

Bachelor's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related discipline.

10+ years of analytical chemistry experience in pharmaceutical, biotechnology, or similarly regulated environments.

Strong GMP QC laboratory experience with raw material, in-process, and finished-product testing.

Strong hands-on experience with HPLC/UPLC and GC.

Experience with analytical method validation, verification, transfer, and troubleshooting.

Strong OOS/OOT and laboratory investigation experience.

Knowledge of FDA 21 CFR Parts 210/211, USP, ICH Q2(R2), ICH Q14, 21 CFR Part 11, ALCOA+, and Good Documentation Practices.

Strong understanding of laboratory data integrity and pharmaceutical QC practices.

Preferred Qualifications

GMP laboratory auditing, assessment, or remediation experience.

Laboratory technical lead, SME, supervisory, or management experience.

FDA inspection or internal audit experience.

Experience with Empower or equivalent chromatography data systems.

Experience supporting multiple manufacturing facilities.

Strong technical writing, assessment, communication, and stakeholder management skills.

Salary

The hourly rate for this position is $45-60 per hour.

Benefits

This is a contract position and does not include employer-provided benefits.

Equal Opportunity Employer

We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background Check

Background checks may be conducted in accordance with applicable law.