QC Data Analyst

Join the Quality Control team in Rensselaer, NY to compile and trend QC release data that supports documentation, lot release, and regulatory reporting.

Responsibilities

• Compile internal and external datasets to support Certificate of Analysis (CofA) and Summary of Analysis (SoFA) materials for lot release
• Trend QC product release data to enable lot release decisions, regulatory filings, and deep-dive product reviews
• Produce annual product release and lot-specific trending reports
• Collaborate with Manufacturing, QA, RA, R&D, and Process Analytical Sciences to share status updates and trending outputs for investigations and validation studies
• Build and maintain tracking matrices and QC metrics covering release activities and stability testing review status
• Support the product release data trending program, including process improvements aimed at streamlining review and release
• Maintain and update SOPs for data review and reporting while ensuring cGMP compliance
• Meet assigned timelines and represent Quality Control in meetings with Drug Supply, External Manufacturing, and QA

Requirements

• BS/BA in Chemistry or Biology (or related field), or an equivalent combination of education and experience
• Ability to comply with applicable cGMP regulations, SOPs, and regulatory agency requirements
• Ability to meet specified timelines supporting lot release and regulatory filings
• Willingness to participate in required training activities
• Experience working in a cGMP pharmaceutical Quality Control laboratory

Salary & Work Model

• Hourly range: $21.78 - $33.99
• Location: Rensselaer, NY (onsite)
• Work model: On-site

Benefits

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Insurance benefits (medical, dental, vision, life, and disability)
• Paid time off
• Family support benefits