Quality Assurance (QA) Specialist I

Position Summary: 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.

Key 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
• Budgets their time with minimal supervision to effectively carry out assigned tasks and proposes improvements to processes across the QA lab.
• Takes initiative to be a key player in team activities.
• Understands, implements, and maintains a safe work environment and good manufacturing practices with respect to procedural requirements and laboratory records and requirements
• Maintains lab for safety and compliance.
• Maintains training certificates as needed for assigned job tasks.
• Interprets data results for conformance with expected results as defined per procedures
• Understands laboratory techniques and principles performed and can independently troubleshoot and resolve analytical techniques and instrument issues.
• Understands, implements and maintains GxP with respect to laboratory records, procedures and systems in accordance with procedural requirements

Qualification & Experience:

• Bachelor's degree in science or technology
• 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