Data Integrity Analyst

Job Description

We are seeking a Data Integrity Analyst to support a proactive Inspection Readiness Supply Chain project as part of a broader IMSC initiative. This role will be lab‑equipment focused and aligned closely with the Equipment Lifecycle Management (ELM) function within Quality Control labs in Malvern, PA. This individual will initially support foundational equipment lifecycle management activities (including vendor escorting and equipment coordination) to enable senior technical SMEs to focus on advanced remediation efforts. Over time, the role will transition into a data integrity–focused position, supporting system risk assessments, data process flow mapping, and GMP documentation related to laboratory equipment and associated systems.

Key Responsibilities

• Support QC laboratory equipment activities aligned with ELM processes, including vendor escorting, coordination of preventative maintenance, and basic equipment lifecycle support
• Assist with the assessment of data process flows for laboratory equipment and associated systems
• Participate in data integrity risk assessments related to equipment data, system use, and documentation practices
• Author and contribute to GMP documentation, including risk assessments, reports, and supporting quality records
• Partner with ELM SMEs to evaluate equipment onboarding, qualification status, and system integrity
• Support proactive inspection readiness efforts by identifying potential data integrity gaps across lab systems
• Collaborate with Quality, Automation, and Manufacturing stakeholders as needed to support identified remediation initiatives

Required Skills & Experience

• Bachelor’s degree (scientific or technical discipline required)
• 2–6 years of hands‑on technical experience (4 years ideal) supporting laboratory or regulated equipment environments
• Exposure to GMP‑regulated environments (21 CFR Part 11 familiarity strongly preferred)
• Technical exposure to a variety of QC lab equipment
• Experience supporting or participating in risk assessments, system evaluations, or inspection readiness activities
• Understanding of data integrity principles within laboratory systems
• Strong GMP documentation skills, including technical writing of reports or assessments
• Comfortable working in a highly regulated, onsite laboratory environment

Nice to Have Skills & Experience

• Prior experience supporting ELM or QC laboratory equipment
• Exposure to systems such as Comet, Empower, SAP, Meridian, TruVault, or KNEAT (not required)
• Experience supporting equipment onboarding, installation, or qualification documentation

Compensation

$38-45/hr

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefits

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.