QC Data Analyst

Regeneron

Regeneron is looking for a QC Data Analyst to support the critical materials and quality control functions at their Limerick Manufacturing site. This role includes working with team members from various departments, ensuring compliance with cGMP regulations, and maintaining data integrity and timeliness.

In this role you can expect to have the responsibilities:

• Compile internally and externally generated data for CofAs and SofAs
• Prepare and provide CofAs and SofAs for all lot release materials
• Coordinate with manufacturing, QA, RA, and R/D for status updates
• Trend QC product release data to support lot release and regulatory filings
• Act as a liaison between QC, Process Analytical Sciences, and Manufacturing
• Support manufacturing investigations and validation studies
• Implement and maintain product release data trending programs
• Present trending data at product review meetings
• Write product annual release data trending reports
• Write lot specific data trending reports
• Prepare matrices to track testing and review status
• Compile data to support QC department metrics
• Assist with process improvement efforts
• Attend meetings to update on release data status
• Ensure compliance with cGMP regulations and SOPs
• Maintain and update relevant SOPs
• Meet timelines for releases and regulatory filings
• Participate in training activities

This role comes with the following benefits:

• Health and wellness programs
• Fitness centers
• Equity awards
• Annual bonuses
• Paid time off

This role requires you to have:

• Quality system delivery
• Data Analysis
• Communication

You would benefit from having:

• Statistics
• Relational Databases
• Microsoft Excel

Regeneron is committed to diversity and inclusion in the workplace. The company provides equal employment opportunities to all qualified applicants and will provide reasonable accommodations for disabilities or chronic illnesses. Background checks are part of the recruitment process to verify candidate information.