Data Analyst

KKR Consulting; United States; Remote; USD 70,000 - 90,000; Full time

Job summary

A leading consulting firm is seeking a Validation Data Analyst to support Quality and Validation teams. The role involves analyzing qualification data to ensure compliance with GMP standards, maintaining data integrity, and preparing documentation for audits. The ideal candidate will have a Bachelor’s degree in a related field and 3–5 years of experience in validation support. This position is fully remote and offers the opportunity for contract employment in a dynamic and regulated environment.

Qualifications

• 3–5 years of experience in validation support, GMP environments, or quality data analysis.
• Strong understanding of validation lifecycle principles (IQ/OQ/PQ).
• Knowledge of data integrity principles (ALCOA+).

Responsibilities

• Collect, compile, and trend data from validation and qualification reports.
• Analyze qualification results to identify patterns and improvement opportunities.
• Develop summary reports and documents for CAPA and process optimization.

Skills

Data trending

Technical writing

Cross-functional collaboration

Quality data analysis

Education

Bachelor's degree in Engineering, Life Sciences, or a related technical field

Job description

Validation Data Analyst – Quality Systems (100% Remote)

Duration: 12 Months

Location: Remote

Overview

The Validation Data Analyst will support Quality and Validation teams by evaluating process and equipment qualification data to ensure compliance with GMP and regulatory standards. The role focuses on maintaining data integrity, supporting audit readiness, and enabling continuous improvement through structured data analysis and clear documentation.

Key Responsibilities

• Collect, compile, and trend data from validation and qualification reports (IQ/OQ/PQ).
• Analyze qualification results to identify patterns, deviations, and improvement opportunities.
• Develop summary reports and technical documentation to support CAPA, risk assessments, and process optimization.
• Ensure complete traceability, accuracy, and data integrity (ALCOA+) across validation documentation.
• Collaborate with Quality, Validation, Manufacturing, and Engineering teams to prepare audit-ready validation summaries and supporting materials.
• Maintain strict compliance with GMP, quality system requirements, and internal documentation procedures.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• 3–5 years of experience in validation support, GMP environments, or quality data analysis.
• Strong understanding of validation lifecycle principles (IQ/OQ/PQ) and qualification documentation.
• Proficiency in data trending, report preparation, and technical writing.
• Knowledge of data integrity principles (ALCOA+).
• Ability to work cross-functionally and manage documentation in a regulated environment.

Seniority level

Mid‑Senior level

Employment type

Contract

Job function

Software Development and Engineering Services