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- New York, New York, United States
- New York, New York, United States
Über
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
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Sprachkenntnisse
- English
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