Quality Assurance (QA) Specialist I Full Time

Job Description:

• Recent Bachelor’s degree in science or technology
• Academic or post grad Lab Experience; Device background preferred
• Agile; Can effectively manage time and handle multiple tasks
• Solid written/ verbal communication skills and interpersonal skills
• Critical thinking skills
• The Quality Assurance (QA) Specialist I is responsible for product complaint documentation, investigations, identification of product defects and/or damage, and summarizing investigational data into a complaint handling system.
• Individual uses expertise and a thorough thought process to determine next step in testing.
• They will perform the complaint return sample testing and investigation (across multiple products).
• The individual will analyze and test routine to medium complexity products and evaluate results. Individual has responsibility for completing assigned work tasks and goals and can independently prioritize work schedule in order to meet both objectives.
• Review & approve other simple to medium complexity investigation results, under the guidance of senior lab analysts.

Responsibilities

• Perform product complaint documentation, investigation, and review of all non-medical complaint content. Analyze and test routine to medium complexity products, and evaluate results. Performs test methods as written to support product complaint investigation activities.
• Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GLP. This requires good analytical skills, technical writing, and good documentation. Responsible for complaint data meeting all regulatory requirements.
• Identification and initiation of appropriate exception documents in accordance with procedural requirements; supports the investigation process
• Supports redline changes to local documents; Supports team to meet broader business objectives; Assists in projects and activities

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