Quality Analyst in Plantation, FL

Quality Analyst I

M-F 8-5pm with 2 Saturdays per month

POSITION SUMMARY:

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 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.
• Responsible for complaint investigations; assist with weekly and monthly metrics.
• Process change controls and update as needed.
• Prepare APR contributions for complaints, investigations to show product performance and determine compliance.
• Prepare monthly and quarterly Complaints metrics for Quarterly Council.
• Coordinate with other department to complete investigations and reports.
• Attend Quality Council meeting and present area results.
• 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 controls.
• Provide guidance and coaching to employees on GMP and Quality Systems aspects.
• 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.

POSITION REQUIREMENTS

Education/Certification/Experience:

Minimum Qualifications:

• Bachelor Degree in Science, Engineering or related field from an accredited college or university, and a minimum of five (5) – seven (7) years related experience preferably in a quality assurance environment; or an equivalent combination of education and/or experience.

Skills/Knowledge/Abilities:

• Current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs) and Food and Drug Administration (FDA), and other regulatory compliance regulations and standards.
• Quality control practices in the pharmaceutical industry.
• Leadership, project management and training methods and techniques.
• Sampling techniques and method for assigned area.
• Labeling processes and techniques.
• Business, scientific and personal computer hardware and software applications.
• Principles of mathematics and statistical computations.
• Current Company policies, practices and procedures, including safety rules and regulations.

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