Quality Analyst II - Quality on the Manufacturing Floor

Role Summary

The Quality Analyst II - Quality on the Manufacturing Floor is responsible for performing QA activities to support biologics manufacturing of cell bank, bulk drug substance, drug product, and placebo. Responsibilities include ensuring manufacturing activities are performed and documented in accordance with current Good Manufacturing Practices (cGMP), providing QA support for product and equipment changeovers, and reviewing and approving batch records, deviations, CAPAs, and controlled documents.

Responsibilities

• QA on the Manufacturing Floor, supporting manufacture of Cell Bank, Bulk Drug Substance, and Drug Product, as well as oversight of media fills
• Ensure manufacturing activities are performed and documented using current Good Manufacturing Practices
• Provide QA support for product and equipment changeovers
• Review and approve executed batch records
• Review manufacturing data and supportive data for equipment and utilities
• Review and approve deviations and CAPAs
• Review and approve controlled documents, including SOPs, Work Instructions, and Forms
• Support site efforts to ensure compliance with Teva Policies and Standards, regulatory requirements, and GMP guidelines
• Use of Veeva, SAP, TevaDoc, LIMS, and TevaLMS to execute GMP QA activities as applicable

Qualifications

• BS/BA (or higher) degree in applicable discipline, preferably life science
• Minimum 2 years experience in cGMP documentation and biopharmaceutical/Biologics/large molecule products, or equivalent
• Knowledge of GMP regulations and quality compliance (cGMP, ICH, FDA, EMA, MHRA, USP/EP policies and guidelines)
• Good oral and written communication skills
• Detail oriented with strong organizational skills
• Team player, able to work collaboratively with all levels of QA and Manufacturing personnel
• Proficient with Microsoft Word and Excel