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Senior Analytical Chemistry Laboratory Consultant
Job Location:
Job Location:
Mundelein, IL - USA
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
29 September 2026 (3 days ago)
Posted:
Application Deadline:
27 December 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
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.
PROJECT OVERVIEW
Education
The ideal candidate is a senior pharmaceutical analytical chemist who has managed audited or served as a technical SME within a GMP Quality Control chemistry laboratory. The individual should have substantial hands-on familiarity with raw material in-process and finished product release testing and understand how analytical laboratory activities function within an effective pharmaceutical quality system.
The strongest candidate will have significant experience with chromatographic and compendial analytical methods analytical method validation and transfer OOS/OOT investigations laboratory data integrity and analytical equipment and computerized systems. Experience participating in FDA or other regulatory inspections conducting laboratory audits and remediating significant laboratory compliance deficiencies is highly desirable.
For this assignment the consultant must be able to go beyond performing a document or SOP review. The individual should be capable of observing actual laboratory practices interviewing analysts and management reviewing raw analytical data and representative investigations assessing analytical methods and laboratory controls and determining whether the laboratory is operating in a state of control and whether the data it generates are scientifically sound reliable and suitable to support material and product release decisions.
VTI Life Sciencesstrives to maintain and inspire professional excellence by providing Commissioning Qualification Quality Engineering Automation and Validation Services to the Pharmaceutical Biotechnology Biologics and Medical Device professional development training competitive compensation excellent benefits a matching 401K and a stimulating collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust respect openness teamwork creative talent enthusiasm and diligence.
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.
PROJECT OVERVIEW
- Location: Mundelein IL
- Start Date: September 2026
- Employment Classification: Contract
- Length of Project: Approximately 4-6months
- Will need to be onsite for 1 week for kickoff then remote
- 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 observations compliance gaps risks and recommended corrective actions.
- Present and discuss assessment findings with laboratory management Quality manufacturing-site representatives and other stakeholders.
Education
- Bachelors degree in Chemistry Analytical Chemistry Pharmaceutical Sciences or a closely related scientific discipline.
- Masters degree or Ph.D. in Chemistry Analytical Chemistry or Pharmaceutical Sciences is preferred but not required.
- Minimum 10 years of analytical chemistry experience within the pharmaceutical biotechnology or similarly regulated industry preferably including significant experience in a GMP Quality Control laboratory.
- Extensive experience with raw material in-process and/or finished product testing in a GMP environment.
- Strong hands-on knowledge of analytical laboratory techniques preferably including HPLC/UPLC and GC as well as common compendial chemical and physical testing methods.
- Demonstrated experience with analytical method validation verification transfer and troubleshooting.
- Strong experience investigating OOS/OOT and atypical analytical results.
- Experience assessing or auditing GMP analytical laboratories strongly preferred.
- Previous laboratory supervisory management technical-lead or analytical SME experience preferred.
- Experience supporting FDA inspections other regulatory inspections internal audits or laboratory remediation activities highly desirable.
- Experience with laboratory computerized systems and chromatography data systems such as Waters Empower or equivalent systems is desirable.
- Experience with laboratories supporting multiple manufacturing facilities is preferred.
- FDA 21 CFR Parts 210 and 211 particularly laboratory control requirements under 21 CFR Part 211 Subpart I.
- USP General Chapters applicable to analytical laboratory operations and testing.
- USP requirements governing compendial methods method verification analytical procedure validation and instrument qualification.
- ICH Q2(R2) Validation of Analytical Procedures.
- ICH Q14 Analytical Procedure Development.
- FDA guidance and regulatory expectations regarding investigation of OOS laboratory results.
- FDA expectations regarding pharmaceutical laboratory data integrity.
- 21 CFR Part 11 as applicable to laboratory electronic records and computerized systems.
- ALCOA data integrity principles.
- Good Documentation Practices (GDP).
- Analytical method lifecycle transfer verification validation and change-control principles.
- Current industry practices for pharmaceutical Quality Control laboratory operations.
- Strong technical knowledge of pharmaceutical analytical chemistry and GMP Quality Control laboratory operations.
- Ability to assess analytical practices from both a scientific and regulatory compliance perspective.
- Ability to distinguish regulatory requirements from industry best practices and identify situations requiring documented scientific justification.
- Strong understanding of analytical method performance and the ability to recognize technically questionable laboratory practices or data.
- Strong knowledge of OOS/OOT investigations and the ability to evaluate whether laboratory investigations are scientifically justified and sufficiently thorough.
- Strong understanding of laboratory data integrity principles and electronic analytical data.
- Excellent observational interviewing and auditing skills.
- Ability to identify systemic laboratory and quality-system weaknesses rather than focusing solely on individual procedural deficiencies.
- Strong technical writing skills and ability to clearly communicate observations risks and recommended corrective actions.
- Ability to interact effectively with laboratory analysts laboratory management Quality personnel manufacturing representatives and senior leadership.
- Ability to work independently and exercise sound scientific and regulatory judgment.
- Practical risk-based approach to compliance and remediation.
The ideal candidate is a senior pharmaceutical analytical chemist who has managed audited or served as a technical SME within a GMP Quality Control chemistry laboratory. The individual should have substantial hands-on familiarity with raw material in-process and finished product release testing and understand how analytical laboratory activities function within an effective pharmaceutical quality system.
The strongest candidate will have significant experience with chromatographic and compendial analytical methods analytical method validation and transfer OOS/OOT investigations laboratory data integrity and analytical equipment and computerized systems. Experience participating in FDA or other regulatory inspections conducting laboratory audits and remediating significant laboratory compliance deficiencies is highly desirable.
For this assignment the consultant must be able to go beyond performing a document or SOP review. The individual should be capable of observing actual laboratory practices interviewing analysts and management reviewing raw analytical data and representative investigations assessing analytical methods and laboratory controls and determining whether the laboratory is operating in a state of control and whether the data it generates are scientifically sound reliable and suitable to support material and product release decisions.
VTI Life Sciencesstrives to maintain and inspire professional excellence by providing Commissioning Qualification Quality Engineering Automation and Validation Services to the Pharmaceutical Biotechnology Biologics and Medical Device professional development training competitive compensation excellent benefits a matching 401K and a stimulating collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust respect openness teamwork creative talent enthusiasm and diligence.
Required Experience:
Manager
About Company
VTI has successfully managed and executed hundreds of validation services projects for Pharmaceutical, Biotechnology and Medical Device manufacturers.
