Data Integrity Analyst u2013 Equipment Lifecycle ...

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 labu2011equipment 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 integrityu2013focused 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 We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: Skills and Requirements Bacheloru2019s degree (scientific or technical discipline required) 2u20136 years of handsu2011on technical experience (4 years ideal) supporting laboratory or regulated equipment environments Exposure to GMPu2011regulated 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 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

Created: 2026-04-20