Senior Scientist I, QC

Senior Scientist, QC

Department

Quality Control (QC)

Location

WuXi Biologics in Cranbury, NJ

Job Summary

The Senior Scientist is responsible for providing statistical and data analytical support for Quality Control testing activities. This role focuses on assay performance monitoring, stability, laboratory data trending, analytical method lifecycle management, and quality risk assessment while ensuring compliance with cGMP regulations, Data Integrity requirements, and internal quality procedures.

The successful candidate will perform data review and analysis, monitor analytical performance, identify trends, support laboratory investigations, and enable data-driven quality decisions.

Key Responsibilities

Assay Performance Monitoring & Trending

• Design and maintain statistical monitoring programs for QC assays and analytical methods, including control charts, trend analysis, capability assessment, and lifecycle performance monitoring.
• Analyze QC-generated data (release, stability, in-process, and characterization testing) to identify analytical variation, detect trends, and support root cause investigations.
• Develop monitoring limits, dashboards, statistical reports, and performance metrics to support quality oversight, regulatory compliance, and continuous improvement.
  
  

Data Review & Data Integrity

• Ensure all laboratory records comply with Good Documentation Practices (GDP) and ALCOA Data Integrity principles.
• Review analytical data, calculations, statistical outputs, and test documentation for accuracy, completeness, and compliance.
• Perform scientific data interpretation and support laboratory data trending activities.
• Support data governance and data integrity initiatives to ensure reliability, traceability, and consistency of analytical data.
  
  

GMP Compliance & Quality Systems

• Participate in deviations, OOS/OOT investigations, CAPAs, and change controls, and trend-related assessments through statistical evaluation and data analysis.
• Support root cause analysis, risk assessments, impact assessments, corrective actions, and effectiveness verification.
• Author, revise, and review statistical reports, trend reports, protocols, SOPs, monitoring plans, and controlled quality documents.
• Ensure activities comply with cGMP requirements, Data Integrity principles, and internal quality procedures.
  
  

Inspection Readiness & Continuous Improvement

• Maintain analytical data, statistical monitoring programs, reports, and documentation in an inspection-ready state.
• Support regulatory inspections, client audits, and internal audits.
• Collaborate effectively with Quality Assurance, Manufacturing, Process Development, MSAT, Analytical Development, and other cross-functional teams.
• Participate in continuous improvement and digital transformation initiatives to improve data visibility, process understanding, operational efficiency, and regulatory compliance.
  
  

Required Qualifications

Education

Master degree in Statistics, Engineering, Life Sciences, or related field

Experience

• 5 years of relevant experience, solid foundation in statistics with hands-on CPV, SPC, or process analytics; proven application of multivariate analysis, statistical modeling, DV/CAPA support, and regulatory engagement (e.g., FDA/EMA audits)
  
  

Knowledge & Skills

• Knowledge of cGMP regulations, pharmaceutical quality systems, and lifecycle management principles.
• Understanding of Data Integrity requirements and Good Documentation Practices (GDP).
• Knowledge of statistical methodologies including trend analysis, control charts, capability analysis, and monitoring strategies.
• Ability to independently organize, analyze, interpret, and communicate scientific and operational data.
• Experience with statistical and data analytics tools such as Minitab, JMP, SIMCA, R, Python, Power BI, or equivalent platforms.
• Strong technical writing, documentation, and presentation skills.
• Excellent attention to detail, problem-solving, and organizational abilities.
• Effective verbal and written communication skills.
• Ability to work independently and collaboratively in a fast-paced GMP environment.
  
  

Preferred Qualifications

• Experience supporting assay trending, laboratory performance monitoring, or data analytics programs in a GMP-regulated environment.
• Experience supporting clinical and/or commercial biologics manufacturing programs.
• Experience developing dashboards, automated reports, or statistical monitoring solutions.
• Familiarity with LIMS and electronic quality management systems.
• Experience supporting regulatory inspections, customer audits, and inspection readiness activities.
• Knowledge of OOS, OOT, deviation, CAPA, and change control processes.
• Experience applying multivariate analysis, predictive analytics, or AI/ML approaches to quality and process monitoring.
  
  

Core Competencies

• Quality & Compliance Mindset
• Statistical Thinking & Data Analytics
• Data Integrity & Documentation Excellence
• Scientific Problem Solving
• Critical Thinking & Risk Assessment
• Continuous Improvement Mindset
• Accountability & Ownership
• Cross-Functional Collaboration
• Inspection Readiness
• Attention to Detail
• Effective Communication
  
  

The salary range for this positoin is $72,800 - $116,500.00