Auditor (GLP)
NAMSA pioneered the industry, NAMSA was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry.
We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization whose:
- Mission is to make a scientific contribution to every medical device in the world.
- Culture is passionately committed to the partnership between one another and our clients to improve and save lives through a respectful, trusting, and collaborative environment.
- Values have stood the test of time.
- Above all else, conduct ourselves with integrity
Job Description:
- Evaluate data and/or lab work to assess compliance with quality system regulations (ISO, GLP, etc.) and SOPs.
- Review records for accuracy, consistency, and compliance.
- May participate in audits of NAMSA facilities, suppliers and agencies.
- Perform periodic audits/inspections of internal operations to assess internal performance and detect quality problems.
- May investigate source of quality problems and makes suggestions for improvements.
- May assure corrective action is taken through follow up activities.
Qualifications & Technical Competencies:
- Requires a Bachelor’s degree in a scientific discipline or an Associate’s degree with at least 2 years of experience in a GLP testing laboratory.
- Requires 0-2 years auditing experience.
- Fluency in English is preferred.
- Maintain personal and professional competency in Quality Assurance and the biomedical industry in general.
- Awareness of issues of control for scientific bias
- Knowledge of statistics and metric system
- Knowledge of use of biostatistics, statistical process control techniques, and test validation methods
- Knowledge of GMP/GLP regulations, as appropriate
- Fundamentals of technical writing
Working Conditions:
- Physical activities include walking, sitting and standing for various periods.
- Physical requirements include being able to occasionally move or lift up to 25 pounds (12 kgs).
- Specific vision abilities include close vision, color vision, and ability to adjust focus.
- Employee must be able to talk and hear.