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
• Duration: 2-3 months contract

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.