Senior Laboratory Data Integrity Specialist

The Data Integrity Specialist Senior Level provides quality assurance and compliance support for quality control laboratory operations within a regulated environment. This role focuses on data integrity, documentation review, laboratory systems oversight, and equipment compliance to ensure adherence to internal procedures and applicable regulatory standards. The position collaborates closely with laboratory, quality, and cross-functional teams to maintain inspection readiness and continuous improvement.

• Serve as a quality compliance specialist supporting quality control laboratory operations and data integrity activities
• Conduct routine assessments of laboratory compliance and communicate findings to laboratory leadership
• Coordinate laboratory reviews of compendial changes and support impact assessments and verification activities
• Oversee laboratory calibration activities including service scheduling, documentation review, and investigation support
• Support procurement, installation, calibration, qualification, and decommissioning of laboratory instruments
• Review quality control documentation to ensure compliance with internal procedures and regulatory requirements
• Identify gaps within quality systems and implement corrective and improvement actions
• Lead or support quality documentation projects related to laboratory equipment and systems
• Participate in validation and qualification review activities for laboratory equipment
• Support development, revision, and delivery of training materials for laboratory teams

• Bachelor’s degree in a scientific or technical discipline
• Extensive experience working in a regulated laboratory environment
• Strong background in data integrity and documentation review
• Hands‑on experience with laboratory systems such as Empower, laboratory information management systems, and electronic laboratory notebooks
• Solid understanding of good manufacturing practices and quality systems
• Strong written and verbal communication skills
• Ability to work collaboratively across cross‑functional teams

• Experience supporting quality control laboratory operations
• Familiarity with laboratory instrumentation and test method requirements
• Experience leading or coordinating quality or compliance initiatives

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.