Quality Analyst III
Date: Apr 5, 2021
Location: Sunrise, Florida, US, 33325
Company: Teva Pharmaceuticals
Company Info
If you’re like people at Teva, you dare to be different. We’re making well-being a way of life for ourcustomers and our colleagues. Join us in helping to make healthcare more accessible to more patients,while supporting one of the most innovative teams in the industry.
Teva’s Davie and Sunrise (Florida) production sites are two of our largest launch facilities. We arestrengthening and adding to our critical teams with great talent and capabilities. Teva, a globalorganization, with a brand of evolving success. Be part of it!
We offer a competitive benefits package including Medical, Dental, Vision and Prescription coveragestarting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the401(k), Employee Stock Purchase Plan and Tuition Assistance
Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed toimproving health and increasing access to quality health solutions worldwide. Our employees are at the core ofour success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 millionpeople every day. We offer a uniquely diverse portfolio of products and solutions for patients and we have built apromising pipeline centered around our core therapeutic areas. We are continually developing patient-centricsolutions and significantly growing both our generic and specialty medicines business through investment inresearch and development, marketing, business development and innovation. This is how we improve health andenable people to live better, healthier lives. Join us on our journey of growth!
Job Description
Under limited supervision, this position is responsible for coordinating investigations into product complaints. Authors and compiles Annual Product Reviews and generates quarterly and yearly Quality Review Reports. Monitors and trends key areas and indicators from production and laboratories for implementation of correctiveand preventative measures.
ESSENTIAL AREAS OF RESPONSIBILITY
• Carries out responsibilities in accordance with the organization’s policies, procedures, and state, Federal andlocal laws.
• Responsible for complaint investigations; assist with weekly and monthly metrics.
• Provide sub reports for APR, annual product review.
• Process change controls and update as needed.
• Prepare APR report to show product performance, validation status and determine compliance.
• Prepare monthly and quarterly APR metrics for Quarterly Council.
• Coordinate with other department to complete investigations and reports.
• Create quarterly APR schedule.
• Attend Quality Council meeting and prepare meeting minutes.
• Responsible for submitting change control.
• Responsible for completing investigations.
• Participates in Audits.
• Review and approve documents in trackwise, (Deviations, CAPAS, LIR, and effectiveness check).
• Review and approve protocol reports, change control and cleaning validation.
• Provide guidance and coaching to employees.
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner inaccordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), and StandardOperating Procedures (SOP’s) instructions.
• Responsible for performing additional related duties as assigned.
Qualifications
Bachelor Degree in Science, Engineering or related field from an accredited college or university, and a minimumof five (5) years related experience preferably in a quality assurance environment
Function
Sub Function
Reports To
QA Manager
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Nearest Major Market: Fort Lauderdale
Nearest Secondary Market: Miami