Senior Analytical Chemistry Laboratory
Fusion Life Sciences Technologies (www.fusionlifesolutions.com) is a WBE-certified Healthcare Staffing and Engineering Services provider supporting industries including Pharma, Medical Devices, Aeronautical, Supply Chain, Heavy/Light Industrial, Food & Beverage, and Automotive. We proudly partner with 120+ clients such as Johnson & Johnson, Haemonetics, Delta, Caterpillar, Artisan Chef, Baxter, and many more. Our wide network of consultants and contract-to-hire engineers brings deep expertise across Engineering, Technical, Administrative, Healthcare, Life Sciences, Blue Collar, Skilled Trades, IT, Software Development, Manufacturing, and Supply Chain sectors.
Senior Analytical Chemistry Laboratory Consultant
Location: Mundelein, IL | Contract: 4-6 months | Onsite: 100%
Role:
Assess and improve GMP QC chemistry laboratory operations supporting raw material, in-process, and finished product release testing across multiple manufacturing sites. Evaluate laboratory methods, equipment, computerized systems, documentation, data integrity, and quality controls against FDA cGMP, USP, and industry standards.
Key Responsibilities:
- Assess compendial/non-compendial methods, HPLC/UPLC, GC, UV-Vis, FTIR, TOC, pH, conductivity, Karl Fischer, titration, dissolution, and other analytical testing.
- Review method validation, verification, transfer, suitability, troubleshooting, and method performance.
- Evaluate equipment qualification, calibration, maintenance, system suitability, and performance controls.
- Assess Waters Empower/chromatography systems, electronic records, audit trails, user access, data review, and ALCOA+ data integrity.
- Review OOS/OOT, deviations, atypical results, investigations, root cause, CAPA, trending, and statistical review.
- Review SOPs, specifications, protocols, worksheets, CoAs, laboratory documentation, and change controls.
- Assess laboratory workflow, sample/standard controls, manufacturing-site interfaces, and product release processes.
- Identify compliance gaps and risks and develop practical, risk-based remediation/improvement recommendations.
- Prepare assessment reports and present findings to Laboratory, Quality, Manufacturing, and senior stakeholders.
Required Qualifications:
- Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field.
- 10+ years analytical chemistry experience in pharmaceutical, biotechnology, or similarly regulated industry.
- Strong GMP QC laboratory experience with raw material, in-process, and/or finished product testing.
- Strong hands-on HPLC/UPLC and GC experience.
- Experience with method validation, verification, transfer, troubleshooting, and OOS/OOT investigations.
- Experience with GMP laboratory assessments/audits preferred.
- Laboratory leadership, technical lead, SME, or management experience preferred.
- FDA/regulatory inspections, internal audits, or laboratory remediation experience highly desirable.
- Experience with Empower or equivalent chromatography data systems desirable.
Technical Knowledge:
FDA 21 CFR 210/211, USP, ICH Q2(R2), ICH Q14, 21 CFR Part 11, ALCOA+, GDP, analytical method lifecycle, validation, transfer, verification, change control, OOS investigations, and laboratory data integrity.
Key Competencies:
Strong analytical chemistry/GMP knowledge, scientific and regulatory judgment, auditing and investigation skills, technical writing, communication, independent decision-making, and risk-based compliance/remediation approach.
Required Qualifications:
- Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field.
- 10+ years analytical chemistry experience in pharmaceutical, biotechnology, or similarly regulated industry.
- Strong GMP QC laboratory experience with raw material, in-process, and/or finished product testing.
- Strong hands-on HPLC/UPLC and GC experience.
- Experience with method validation, verification, transfer, troubleshooting, and OOS/OOT investigations.
- Experience with GMP laboratory assessments/audits preferred.
- Laboratory leadership, technical lead, SME, or management experience preferred.
- FDA/regulatory inspections, internal audits, or laboratory remediation experience highly desirable.
- Experience with Empower or equivalent chromatography data systems desirable.
All your information will be kept confidential according to EEO guidelines.