Job Description
One of our large sterile injectables manufacturing clients is seeking an Operations Associate to assist on their Data Audit Trails process. The Data Audit Trail Operations Associate supports the sterile injectables manufacturing operations by executing routine and periodic audit trail reviews, data integrity checks, and system-level documentation activities across GxP‑regulated computerized systems. This role ensures that electronic records generated throughout manufacturing, quality, and laboratory workflows meet regulatory expectations for accuracy, completeness, and compliance.
The associate works closely with Operations, Quality Assurance, and IT/Automation teams to maintain compliant data practices, strengthen audit readiness, and uphold the clients commitment to safe, sterile, and high‑quality injectable products.
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 HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
Audit Trail Review Execution — Perform scheduled and ad‑hoc audit trail reviews for manufacturing, quality, and laboratory systems (e.g., MES, LIMS, CDS, EBR platforms).
Data Integrity Monitoring — Assess electronic records for ALCOA+ principles, ensuring data is attributable, legible, contemporaneous, original, and accurate.
Sterile Injectables System Support — Review data generated from aseptic processing, batch formulation, filling, lyophilization, and inspection systems.
Exception & Deviation Tracking — Identify irregularities, unauthorized access, or atypical system activity and escalate findings to QA and Operations.
Compliance Documentation — Prepare audit trail reports, data review summaries, and corrective action documentation aligned with SOPs.
Benefit packages for this role will start on the 1st 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.