Quality Data Analyst – NC/CAPA Trending

QSE7 Consulting; Philadelphia (Philadelphia County); A distancia; USD 70.000 - 100.000; Jornada completa

Descripción de la vacante

QSE7 seeks an experienced Quality Data Analyst for a full-time contract with a global life sciences client. You will build NC/CAPA trending, develop SPC charts in Minitab or Excel, and create Power BI dashboards to support QIM decision-making.

Role is remote with Eastern Time hours; initial term is eight months with potential extension. Candidates in the US are preferred, Pennsylvania-based candidates a plus. Strong data analytics, SPC, and QA systems experience are required.

Formación

• Bachelor's degree in Statistics, Engineering, Data Analytics, Life Sciences or related field.
• 5+ years in data analysis or quality analytics in GxP-regulated environments.
• Hands-on experience with statistical process control and control charts (C, U, P).
• Proficiency in Minitab; strong in Excel, JMP, Python or R preferred.

Responsabilidades

• Build and run SPC charts (C, U, P) on NC, investigation, CAPA data using Minitab, Excel or similar tools.
• Design drill-down analyses to link top-level signals to detailed charts and data.
• Define how charts are read: chart selection, control limits, signal rules, follow-up actions.
• Establish a central trending approach across sites; move from site-by-site methods.
• Build Power BI dashboards to visualize trends for central QIM team and stakeholders.
• Extract, clean and structure NC/CAPA data from quality systems for reliable trending.
• Deliver proof-of-concept charts and dashboards, then document requirements for production build.
• Interpret trends and partner with stakeholders to identify next steps.

Conocimientos

Statistical data analysis

Minitab

Excel

Power BI

SQL

Python or R

Educación

Bachelor's degree in Statistics/Engineering/Data Analytics/Life Sciences

Herramientas

Minitab

JMP

Python

R

Descripción del empleo

QSE7, a Pennsylvania-based consulting firm, is seeking to hire an experienced, technically strong Quality Data Analyst for a full-time contract engagement with a global life sciences client. Supporting the client's Quality Issue Management (QIM) organization, you will help build a central trending capability for Non-conformance (NC), investigation and CAPA data. You will develop and interpret statistical process control charts in Minitab or Excel, build Power BI visualizations, and help turn proof-of-concept analyses into a scalable trending approach. Investigation and CAPA experience is a strong plus. This is a remote role, with Eastern time zone hours preferred. The initial term is full-time for approximately eight months, with potential extension.

Job 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.

Qualifications

• 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; SQL experience is a plus.
• Working knowledge of Non-conformance, investigation and CAPA processes, including root cause categorization; hands-on investigation or CAPA experience strongly preferred.
• Experience working with eQMS data (e.g., Veeva Vault QMS, TrackWise) preferred.
• Experience delivering proof-of-concept analytics and handing requirements to development teams is a plus.
• 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.
• Able to work full-time remotely on Eastern time zone hours; Pennsylvania-area candidates are a plus.

About QSE7

- Founded in 2016, QSE7 offers innovative and specialized Information Technology (IT) and Consulting services to FDA-regulated life sciences companies. Our areas of focus include program/project management, process analysis, automated business process improvements, data analytics and reporting, and implementation of IT solutions based on Microsoft technologies, such as Excel, MS Teams, SharePoint, Power BI and Power Automate. We strive to bring automation and efficiency to our clients' processes by providing high-quality and intuitive solutions in an efficient, comprehensive manner.