Teva Pharmaceuticals Life Science Job – Quality Analyst Post
Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day
Job Title: Quality Analyst II – 6009
Location: West Chester, New Jersey, United States, 00000
Job Id: 48146
Your experience and qualifications
• BS/BA or Undergraduate degree in applicable disciple preferably life science.
• Knowledge in Quality Compliance (cGMP/ICHIFDAIUSP/EP policies/guidelines) required. Minimum 2 years QA experience in development of Biopharmaceutical/Biologics/Large Molecule products preferred.
• Proficient with Microsoft Word and Excel.
• Familiar with biopharmaceutical operations and cGMP documentation practices.
• Basic experience with SAP, Trackwise, EDMS, CMMS
The Quality Analyst II is responsible for coordinating activities for site level quality assurance activities related to the release of consumable used in the production facility and/or quality control testing laboratory.
- Ensure activities are performed/completed using current Good Manufacturing Practices.
- Responsible for the establishment and revision of controlled material specifications
Support controlled material disposition
- Revise, review, and approve SOPs, work instructions, and controlled forms.
Serve as Quality resource, representing QA on teams in support of assignments.
- Provide feed-back/communication of any issues.
- Support of manufacturing activities as QA OTF
- Support product dispositioning activities
- Responsible for performing periodic reviews to ensure alignment with current procedures.
- Ensure site alignment with corporate standards and cGMP guidelines and support complete Gap assessments to align with corporate standards
- Review and approval of (but not limited to): Change controls, deviations,
- CAPAs/effectiveness checks, and laboratory investigations in TrackWise.
- Participate/support regulatory agency filings, inspections, and internal audits, as needed.
Teva Pharmaceuticals Life Science