Senior GMP Analytical Chemistry Lab Consultant

Inc. (Vti); Mundelein (IL); On-site; USD 120,000 - 150,000; Full time

Job summary

VTI Life Sciences is seeking a Senior Analytical Chemistry Laboratory Consultant to conduct a comprehensive assessment of a GMP QC laboratory supporting raw material, in‑process, and finished product testing across multiple sites.

The assignment emphasizes laboratory data integrity, method validation/transfer, OOS investigations, and CAPA development, with on-site collaboration in Mundelein, IL for about three months.

Qualifications

• Minimum 10 years of analytical chemistry experience in GMP environments.
• Experience with raw material, in-process, and finished product testing.
• Hands-on knowledge of HPLC/UPLC and GC; familiarity with compendial testing.

Responsibilities

• Assess laboratory operations against FDA cGMP, USP, and industry practices.
• Evaluate methods, validation/transfer, equipment, and data integrity.
• Identify compliance gaps and recommend CAPAs and pragmatic remediation.
• Prepare and discuss assessment findings with stakeholders.

Skills

GMP QC operations

Analytical method validation

Data integrity

OOS/OOT investigations

Auditing

Technical writing

Independent work

Regulatory perspective

Education

Bachelor's degree in Chemistry orRelated

Master's or Ph.D. preferred

Tools

HPLC/UPLC

GC

UV-Vis

FTIR

TOC

pH/conductivity

Karl Fischer

Waters Empower

Job description

VTI Life Sciences is seeking a Senior Analytical Chemistry Laboratory Consultant to conduct a comprehensive assessment of a GMP QC laboratory supporting raw material, in‑process, and finished product testing across multiple sites.

The assignment emphasizes laboratory data integrity, method validation/transfer, OOS investigations, and CAPA development, with on-site collaboration in Mundelein, IL for about three months.