QC Data Analyst

Regeneron Pharmaceuticals, Inc.; Town of East Greenbush (NY); Sur place; USD 29 000 - 47 000; Plein temps

Avantages offerts par ce poste

Annual bonuses or other incentiveplans

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits (medical, dental, v

Paid time off

Family support benefits

Résumé du poste

Regeneron Pharmaceuticals, Inc. in Rensselaer, NY seeks a QC data analyst to compile internal/external datasets for CofA and SoFA materials supporting lot release and regulatory filings.

You will trend release data, generate annual release and lot-specific reports, and collaborate with Manufacturing, QA, RA, R&D, and Process Analytical Sciences to share findings for investigations and validations. This on-site role emphasizes maintaining QC matrices, ensuring cGMP compliance, and meeting

Qualifications

• BS/BA in Chemistry or Biology or related field.
• Experience in a cGMP pharmaceutical QC lab.
• Ability to meet timelines for lot release and regulatory filings.
• Willingness to participate in required training.

Responsabilités

• Compile internal and external datasets to support CofA and SoFA materials for lot release.
• Trend QC product release data to enable lot release decisions and regulatory filings.
• Produce annual product release and lot-specific trending reports.
• Collaborate with Manufacturing, QA, RA, R&D, and Process Analytical Sciences on status updates.
• Build and maintain tracking matrices and QC metrics for release activities and stability reviews.
• Support data trending program and process improvements for streamlined reviews.
• Update SOPs for data review and reporting ensuring cGMP compliance.
• Represent Quality Control in meetings with Drug Supply, External Manufacturing, and QA.

Connaissances

cGMP compliance

Data trending & analysis

Collaborative teamwork

Formation

BS/BA in Chemistry or Biology

Description du poste

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