Senior Technical Reviewer
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:
Responsibilities:
- 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.
- Negotiate and contract
- Above all else, conduct ourselves with integrity
Job Description:
- Reviews raw data generated by laboratory studies for technical accuracy and completeness.
- Makes approved changes to documents (SOP’s, protocols, worksheets, reports).
- Evaluates, analyzes and interprets data and presents in a clear, well-organized, scientifically sound report for GMP and non-GLP studies as well as reviews for consistency and compliance.
- Responsible for meeting On-time and Revised Report metrics.
- Assists with special protocol and worksheet development, as well as creating protocols for non-GLP testing.
- Handles challenging situations, and knows when to call-in help.
- Interacts as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
- Serves as the primary contact for the client for GMP and non-GLP studies and keeps the client informed of schedule and any unforeseen events or issues, or adverse results.
- Assists with testing in the laboratory as needed.
- Assists with project management as designated by laboratory management.
- Contributes to developing new laboratory assays (feasibility testing, validation work, etc.).
- Assists with logging in testing as needed.
- Subject Matter Expert for laboratory investigations, as assigned by management.
- Other duties as assigned.
Qualifications & Technical Competencies/Principal Duties and Responsibilities
- Reviews raw data generated by laboratory studies for technical accuracy and completeness.
- Makes approved changes to documents (SOP’s, protocols, worksheets, reports).
- Evaluates, analyzes and interprets data and presents in a clear, well-organized, scientifically sound report for GMP and non-GLP studies as well as reviews for consistency and compliance.
- Responsible for meeting On-time and Revised Report metrics.
- Assists with special protocol and worksheet development, as well as creating protocols for non-GLP testing.
- Handles challenging situations, and knows when to call-in help.
- Serves as the primary contact for the client for GMP and non-GLP studies and keeps the client informed of schedule and any unforeseen events or issues, or adverse results.
- Assists with testing in the laboratory as needed.
- Assists with project management as designated by laboratory management.
- Contributes to developing new laboratory assays (feasibility testing, validation work, etc.).
- Assists with logging in testing as needed.
- Subject Matter Expert for laboratory investigations, as assigned by management.
- Other duties as assigned.
Qualifications and Skills:
- Bachelor’s degree in a scientific discipline required.
- 5 years of related laboratory experience.
- 3 years of project management experience, preferred.
- Fluency in English and local language, if different, required.
Working Conditions:
- Physical activities include sitting, walking, using hands to finger, handle or feel, and reaching with hands and arms.
- Vision abilities include close vision, color vision, and ability to adjust focus.
- Physical requirements include being able to frequently move or lift up to 25 pounds.
- Employee must be able to talk and hear.