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The opportunity

The Quality Workflow Coordinator II position is filled by a professional who possesses the compliance and Regulatory knowledge and skills necessary to provide direction and guidance in current Good Manufacturing Practice (cGMP) regulations for commercial and clinical biopharmaceutical manufacturing. The incumbent works to assure the quality, accuracy, and integrity of data in manufacturing operations, and regulatory submissions and to assure that effective and appropriate Quality Management Systems are in place and followed. The incumbent applies experience and excellent communication skills within a collaborative environment to assure that the GMP Quality culture are embraced by the site to enable a commitment to continuous quality improvement and embrace a permanent inspection ready attitude.

The position involves in-depth knowledge of Quality Management System (QMS) and its implementation in relation to the ICH Q7, ICH Q10 and 21 CFR 11/211, Annex 11, and Requirements at the site.

Essential Responsibilities

• Administer periodic review process for SOPs, forms and work instructions
• Update local SOPs, forms and work instructions as applicable
• Support GMP compliance and inspection readiness initiatives
• Ensure prioritized workflow based on document criticality
• Support compliance improvement projects as applicable
• Author and/or Support gap assessments of local SOPs to corporate standards
• Utilize Quality Systems to review and approve change controls, deviations, laboratory investigations, CAPAs and CAPA Effectiveness checks
• Support general QMS activities and initiatives
• Issue logbooks and documentation in support of production and/or laboratories
• Support document workflow troubleshooting as applicable
• Ensure activities are performed/completed using current Good Manufacturing Practices
• Support GMP compliance and inspection readiness
• Support regulatory agency filings and inspections
• Support regulatory agency filings and inspections
• Provide administrative support for the EDMS
• Tracking, Assessing, and Formatting EDMS related document workflow
• Monitor in-progress document workflow throughout lifecycle

Additional Compliance Responsibilities

• Support cross functional department customers in a manner which is clear in approach, communication and action.
• Serve as Quality resource, representing QA on teams in support of assignments.
• Use of Microsoft Word, Excel, and PowerPoint to support compliance team activities.
• Assist in the preparation and presentation of site Quality Council.
• Assist in the planning and execution of Internal Audits.

Your experience and qualifications

• Knowledge in quality compliance (cGMP, ICH, FDA, EMA, USP/EP policies & guidelines) required.
• Minimum 2 Years of experience in development of Biopharmaceutical products and/or commercial pharmaceutical manufacturing required.
• BS/BA or Undergraduate degree in applicable discipline, preferably life science.

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