Role:
As a A quality assurance specialist (QA specialist) you will ensure that our products or services meet established standards and requirements. Monitor processes, inspect products, and analyze data to identify areas for improvement.
ESSENTIAL FUNCTIONS:
Plan, execute, and oversee incoming product inspection and manage testing for quality and conformance to specifications and deliverables
Assist operations by tracking, documenting, and reporting quality levels as well as CSR, environmental, and health and safety KPIs
Ensure site GMP compliance, including documentation, cleanliness, maintenance
Investigate reports of product quality issues and ensure resolution in accordance with company guidelines and regulatory requirements
Develop or update procedures for capture, investigation, and documentation of product complaints
Monitor risk-management procedures, maintain problem logs, and report issues to managers and product developers.
Provide training and support to operational team members that covers systems, policies, procedures, and core processes
SKILLS:
- Understanding of 21 CFR 111 and 21 CFR 117
- Six Sigma Green Belt
- Fluent in English
- Proficiency in Spanish
- Experience in International (Canada & Europe) regulations
QUALIFICATIONS AND EDUCATION REQUIREMENTS:
- Bachelor’s degree (or equivalent) in cGMP/FDA regulated field and 2+ Years of related experience.
- -OR- 5+ Years of equivalent professional QA experience
- Knowledge of quality assurance terminology, methods, and tools
- Excellent analytical, problem-solving, and decision-making skills
- Proficiency in Microsoft Office
- Proficiency in best practices for inspection, version control, and defect management
PHYSICAL REQUIREMENTS:
- Prolonged periods of sitting at a desk and walking the warehouse.
- Must be able to lift up to 15 pounds if needed.