Senior Analytical Chemistry Laboratory

Senior Analytical Chemistry Laboratory Consultant
Location: Mundelein IL Contract: 46 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:

• Bachelors 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.

Qualifications :

Required Qualifications:

• Bachelors 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.

Additional Information :

All your information will be kept confidential according to EEO guidelines.

Remote Work :

No

Employment Type :

Contract