Quality Data Analyst – NC/CAPA Trending

QSE7 Consulting is hiring a Quality Data Analyst for a global life sciences client’s Quality Issue Management organization. The role will develop and interpret statistical process control analyses, build Power BI dashboards, and establish a scalable central trending approach for non-conformance, investigation, and CAPA data.

Responsibilities:

• Build and run statistical process control charts (C, U and P charts) on NC, investigation and CAPA data using Minitab, Excel or similar tools
• Design drill-down analyses so that a signal on a top-level chart leads to the more detailed charts and data that explain it
• Define how each chart is read and used: chart selection, control limits, signal rules and the expected follow-up actions
• Help establish a consistent, central trending approach across manufacturing sites in place of site-by-site methods
• Build Power BI dashboards and visualizations that make trends and signals visible to the central QIM team and site stakeholders
• Extract, clean and structure NC/CAPA data from the quality system, including reason coding and categorization so data can be trended reliably
• Deliver proof-of-concept charts and dashboards against monthly timelines, then document the requirements and logic for hand-off to developers for a production build
• Interpret emerging trends and partner with site and business stakeholders (QM&D, Supply Chain, R&D, Commercial Quality and External Quality) to identify next steps
• Coach site teams on reading and using control charts, since many have limited Minitab experience
• Support the NC/CAPA Global Process Lead with KPI metrics and trend analysis for governance forums
• Provide NC/CAPA data sets and analysis in support of audits and inspections

Requirements:

• Bachelor's degree in Statistics, Engineering, Data Analytics, Life Sciences or a related field
• 5+ years of experience in data analysis or quality analytics in GxP-regulated pharmaceutical, biotech or medical device environments
• Hands-on experience with statistical process control, including building and interpreting attribute control charts (C, U and P charts)
• Proficiency in Minitab; candidates strong in SPC with Excel, JMP, Python or R who can pick up Minitab quickly will also be considered
• Advanced Power BI skills, including data modeling and drill-down dashboards
• Advanced Excel skills
• Ability to explain statistical concepts in plain language to site teams and leadership
• Self-directed, able to ramp up within days and deliver against monthly timelines
• SQL experience
• Working knowledge of Non-conformance, investigation and CAPA processes, including root cause categorization
• hands-on investigation or CAPA experience
• Experience working with eQMS data (e.g., Veeva Vault QMS, TrackWise)
• Experience delivering proof-of-concept analytics and handing requirements to development teams
• Pennsylvania-area candidates