The QA Product Complaints Representative is responsible for improving business processes and supporting customer service interactions to ensure key business objectives are met. The QA Product Complaints individual represents Quality Assurance on projects, including lean initiatives.

Key Objectives / Deliverables:

• Technical knowledge of complaint handling and/or quality systems
• Maintain trend analysis for product and process performance
• Authors, periodic reviews, and acts as Subject Matter Expert for RTP site Product Complaint Management procedures.
• Review/Write/Approve GMP documents including technical reports, deviations, change controls as applicable.
• Perform complaint investigations for RTP manufacturing, assembly, and packaging for drug/device combination products and parenteral products.
• Compile and document monthly metrics/quarterly metrics/ad-hoc reports.
• Compile and present complaint data for process teams, Site Quality Lead Team, and Process Flow team.
• Complete the APR complaints sections for each required product including compiling/summarizing data and presentation support as necessary.
• Participates in CAPA Review Board Meetings for Complaint Investigation CAPA
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Education Requirements:

• Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience.
• At least 2 years working in the pharmaceutical or medical device industry in QA roles.

Additional preferences:

• Ability to compile data and metrics in reports understandable by management and business partners
• Attention to detail, self-management, problem solving; mentoring.
• Proficiency with GMP computer systems including CAPA systems, and Document Control systems.
• Demonstrated strong oral and written communication skills
• Demonstrated strong technical writing skills.