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

• 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

Skills

• Proficient with Microsoft Word and Excel
• Strong documentation and data review capabilities

Education

• BS/BA (or higher) degree in applicable discipline, preferably life science