Validation & Engineering Group
LL01-251028 Laboratory Investigations Specialist
Validation & Engineering Group, De Pere, Wisconsin, United States
Job Description
Validation & Engineering Group, Inc.
(V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Laboratory Investigations Specialist
The
Laboratory Investigations Specialist
is responsible for supporting the Quality Control (QC) and Quality Assurance (QA) teams by leading and documenting
laboratory investigations
related to analytical deviations, out-of-specification (OOS) results, and non-conformances. The role ensures all investigations are performed according to
GMP and regulatory standards , with accurate root cause analysis and timely closure.
Key Responsibilities
Lead and document investigations for
deviations, and equipment failures
within QC laboratories.
Perform
root cause analysis
and identify corrective and preventive actions (CAPA).
Work closely with analysts, supervisors, and QA to ensure accurate data collection and consistent documentation.
Support
CAPA implementation, effectiveness checks, and trending
of recurring issues.
Ensure compliance with
GMP, FDA, and company SOPs
during investigation processes.
Maintain accurate and complete records in electronic quality systems (e.g., TrackWise, Veeva).
Participate in laboratory audits and provide investigation summaries when required.
Support continuous improvement in laboratory processes and data integrity practices.
Qualifications
Education:
Bachelor’s degree in Chemistry, Biology, Biochemistry, or related scientific field.
Experience:
2–5 years in a GMP laboratory or quality role (pharma/biotech preferred).
Knowledge of analytical methods (HPLC, GC, spectroscopy) is a plus.
Strong written communication and documentation skills.
Familiarity with root cause tools (5-Whys, Fishbone diagrams) and CAPA process.
Soft Skills
Detail-oriented and organized.
Strong problem-solving and critical thinking.
Collaborative and comfortable communicating with QA, QC, and management.
Able to prioritize and manage multiple investigations simultaneously.
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(V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Laboratory Investigations Specialist
The
Laboratory Investigations Specialist
is responsible for supporting the Quality Control (QC) and Quality Assurance (QA) teams by leading and documenting
laboratory investigations
related to analytical deviations, out-of-specification (OOS) results, and non-conformances. The role ensures all investigations are performed according to
GMP and regulatory standards , with accurate root cause analysis and timely closure.
Key Responsibilities
Lead and document investigations for
deviations, and equipment failures
within QC laboratories.
Perform
root cause analysis
and identify corrective and preventive actions (CAPA).
Work closely with analysts, supervisors, and QA to ensure accurate data collection and consistent documentation.
Support
CAPA implementation, effectiveness checks, and trending
of recurring issues.
Ensure compliance with
GMP, FDA, and company SOPs
during investigation processes.
Maintain accurate and complete records in electronic quality systems (e.g., TrackWise, Veeva).
Participate in laboratory audits and provide investigation summaries when required.
Support continuous improvement in laboratory processes and data integrity practices.
Qualifications
Education:
Bachelor’s degree in Chemistry, Biology, Biochemistry, or related scientific field.
Experience:
2–5 years in a GMP laboratory or quality role (pharma/biotech preferred).
Knowledge of analytical methods (HPLC, GC, spectroscopy) is a plus.
Strong written communication and documentation skills.
Familiarity with root cause tools (5-Whys, Fishbone diagrams) and CAPA process.
Soft Skills
Detail-oriented and organized.
Strong problem-solving and critical thinking.
Collaborative and comfortable communicating with QA, QC, and management.
Able to prioritize and manage multiple investigations simultaneously.
#J-18808-Ljbffr