• The Quality Analyst II- Quality on the Manufacturing Floor is responsible for performing QA activities, in order to support biologics manufacturing of cell bank, bulk drug substance, drug product, and placebo
• 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

• 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
• 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

• Knowledge of GMP regulations and quality compliance (cGMP, ICH, FDA, EMA, MHRA, USP/EP policies and guidelines)

• We offer a competitive benefits package, including:
• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays
• Life and Disability Protection: Company paid Life and Disability insurance

Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, FlexibleSpending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more. The total compensation may also include restricted stock units and discretionary awards, depending on the position offered *Already Working @TEVA?**