NAMSA Job Opportunities (Continued)

NAMSA is a global medical device research organization providing a comprehensive range of services to prove efficacy, non-clinical and clinical safety of medical devices, IVDs, HCT/P and combination products. NAMSA has breadth and depth in consulting, non-clinical and clinical services with expertise in cardiovascular, orthopedic, ocular, neurologic, gastroenterologic, urologic, combination product and related medical devices.   For more than 45 years, NAMSA clients utilize its testing and consulting services to bring safe and effective products to market.

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).

·         Reviews related documents for consistency and regulatory compliance.

·         Evaluates, analyzes and interprets data and presents in a clear, well-organized, scientifically sound report for GMP and non-GLP studies.

·         Responsible for meeting On-time and Revised Report metrics.

·         Assists with special protocol and worksheet development.

·         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.

·         Other duties as assigned.

Qualifications and Skills

·         Bachelor’s degree in a scientific discipline required.

·         3 years of related laboratory experience.

·         Fluency in English and local language, if different, required.

Technical Competencies

·         Knowledge of statistics and metric system, strong computer skills, technical writing skills.

·         Ability to write and/or edit documents intended for submission to regulatory agencies.

·         The ability to discuss scientific methods and communicate effectively with clients and regulatory agencies.

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.

NAMSA is committed to providing equal employment opportunities (EEO) and treatment for every person seeking employment with or employed by our company.   The Company will not fail or refuse to hire any individual, discharge any individual, or otherwise discriminate against any individual by reason of a person’s race, color, creed, religion, national origin, sex, disability, age, citizenship, veteran status, genetic information, sexual orientation, marital status, gender identity, or status with regard to public assistance or any other characteristic, status, or condition protected by law.   Employment decisions are based solely upon qualifications and merit.  We recognize that diversity and inclusion is a driving force in the success of our company.

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