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Job details:
Experience: 6–10 Years
Location: Singapore
Role Summary
We are seeking a highly skilled Senior QC Sr. Associate with a strong blend of Quality Control (QC) Validation expertise and Data Engineering/Data Science capabilities within the biopharma manufacturing domain.
This role will focus on QC data integration, validation processes, and advanced analytics, enabling data-driven decision-making and predictive insights to improve overall quality processes.
Key Responsibilities
QC Validation & Quality Systems
· Understand and support QC Validation processes aligned with industry standards and practices (e.g., experience in organizations like Amgen or similar).
· Work extensively with Quality Management Systems (QMS) including:
o Deviations
o Non-conformances
o CAPA and change controls
· Ensure adherence to quality control practices in biopharma/life sciences manufacturing.
· Analyze QC data to identify trends, defects, and process inefficiencies.
Data Engineering & Integration
· Design and implement data acquisition and integration pipelines from systems such as LIMS and other QC platforms.
· Extract, transform, and load (ETL) data into AWS S3 using Databricks.
· Develop data workflows to:
o Process and structure QC data
o Enable scalable data storage and access
· Write and optimize scripts using Python and SQL for data processing.
System Integration & Automation
· Build and maintain APIs to integrate with Smartsheet and other enterprise tools.
· Automate data ingestion and reporting workflows across QC systems.
· Ensure data integrity, traceability, and compliance with regulatory standards.
Data Visualization & Reporting
· Develop dashboards and reports using:
o Tableau
o Spotfire
o Power BI
· Generate actionable insights and KPI dashboards related to:
o QC performance
o Defects and deviations
o Process efficiency
· Present insights to stakeholders for informed decision-making.
Advanced Analytics & Data Science
· Collaborate on building machine learning models using QC data for:
o Early defect detection
o Process optimization
· Use predictive modeling to:
o Assess data sensitivity
o Forecast quality risks
· Enable proactive quality management through data-driven insights.
Required Skills & Qualifications
· Strong experience in QC Validation within Biopharma/Life Sciences Manufacturing
· Hands-on experience with:
o LIMS (Laboratory Information Management Systems)
o QMS tools and processes
· Proficiency in:
o Python
o SQL
o Databricks
o AWS S3
· Experience in data integration, ETL, and API development
· Expertise in data visualization tools (Tableau, Spotfire, Power BI)
· Good understanding of machine learning and predictive analytics concepts
· Strong analytical, problem-solving, and communication skills
Preferred Qualifications
· Experience working with global pharma companies (e.g., Amgen or equivalent)
· Knowledge of GxP and regulatory compliance standards
· Exposure to Smartsheet integrations and automation
· Experience in end-to-end data lifecycle management in QC environments
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