Position Overview

The Quality Associate, Biologics plays a pivotal role in overseeing data management for commercial biologics testing, executed by contract laboratories. The role requires proficiency in data review and management using Excel, Minitab, and LIMS systems, as well as familiarity with bioanalytical methods such as HPLC, ELISA, CE, PCR, spectrophotometry, and SDS-PAGE. Success in this position depends on the ability to thrive in a fast-paced, highly technical environment and communicate effectively with internal and external teams.

Essential Functions

• Data Review & Management : Oversee data review and management for routine testing performed by contract laboratories to support commercial biologics.
• Electronic System Proficiency : Utilize Veeva Quality eDocs, Minitab, and other electronic systems to manage data, ensuring data integrity and compliance.
• Statistical Analysis : Perform data trending, interpretation, and statistical analysis for commercial release and stability studies, ensuring consistency in assay controls, reference standards, and invalid assay trending.
• Technical Data Review : Serve as the technical reviewer for data sets, quality records, and lab investigations generated by contract laboratories.
• Authoring Key Documents : Author Certificates of Analysis (CoAs), technical reports, and quality records in accordance with regulatory standards.
• Subject Matter Expert (SME) : Act as an SME for product-specific test methods for both internal and external quality control.
• Cross-Functional Collaboration : Work closely with internal and external cross-functional teams, including CMOs, contract test labs, manufacturing, quality, regulatory, and program management to provide updates, timelines, and manage workflows.
• Reference Standard Monitoring : Monitor and manage product-specific reference standard programs, including qualification and distribution to contract test labs.
• Method Validation Support : Assist with analytical method validation and transfer activities.

Qualifications

Education:

• Associate degree required, BS/BA in Life Sciences or a closely related field preferred.

Technical Experience:

• 3+ years of experience in a cGMP Quality Control, Analytical Development, Analytical Transfer, or Validation department within the pharmaceutical/biotech industry.
• Hands-on experience with bioanalytical methods and equipment such as HPLC, CE, PCR, ELISA, gel-based assays, and other compendial methods.
• Familiarity with method validation, analytical transfers, or laboratory investigations.
• Knowledge of ICH guidelines, regulatory standards for QC operations, laboratory compliance, and data integrity.
• Experience with statistical data analysis using JMP or Minitab.
• Proficiency in Microsoft Office, Veeva Quality systems, and Minitab.