Teva Quality Analyst II 

United States, Florida, Sunrise 

419443290

Under limited supervision, this position is responsible for coordinating investigations into product complaints. Prepares stability reports and analyzes data. Monitors and trends key areas and indicators from production and laboratories for implementation of corrective and preventative measures.

ESSENTIAL AREAS OF RESPONSIBILITY
• Carries out responsibilities in accordance with the organization's policies, procedures, and state, Federal and local laws.
• Prepares Stability reports and analyzes data.
• 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.
• Coordinate with other department to complete investigations and reports.
• Responsible for submitting change control.
• Responsible for completing investigations.
• Review and approve documents in trackwise, (Deviations, CAPAS, LIR, and effectiveness check).
• Review and approve protocol reports, change control and cleaning validation.
• 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 in accordance with company policies and procedures, Good Manufacturing Practices (cGMP's), and Standard Operating Procedures (SOP's) instructions.
• Responsible for performing additional related duties as assigned.

• A minimum of a Bachelor Degree in Science, Engineering or related field from an accredited college or university
• A minimum of three (3) years related experience, preferably in a quality assurance environment.
• Experience with Laboratory Information Systems

Ronnie Gumbs

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