Senior Technologist, In Vitro Biocompatibility

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 50 years, NAMSA clients utilize its testing and consulting services to bring safe and effective products to market.
Principal Duties and Responsibilities
May perform routine test article/product preparation according to work instructions.
May execute routine testing per NAMSA SOPs, with appropriate data analysis.
Performs routine calculations, interprets results, and can route all positive results or unusual testing occurrences to Management.
May provide on the job training.
Assure testing/test article preparation is performed within due dates.
May prepare and maintain cell lines and reagents required for testing, as applicable for primary department.
Maintain relevant supplies, materials, and equipment used in routine testing.
Maintain ancillary records (logbooks, worksheets).
Conduct routine studies independently. May be requested to conduct more involved studies.
Participate in the improvement of documents, test systems, quality systems, and workflow.
May be responsible for checking laboratory equipment, being on-call, and responding to continuous monitoring alarms. The associate will respond in accordance with criteria outlined in Standard Operating Procedures.
May perform Environmental Monitoring, clean and disinfect cleanroom suites.
May order and/or stock supplies subject to approval.
May be required to perform personal gowning environmental testing, and submit organisms from gowning, environmental and sterility test positives for identification and inclusion in monthly trending data.
Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and taking all concerns to management as required.
May be required to operate autoclave.
Qualifications and Skills
Bachelor's degree in scientific discipline appropriate for hiring department and at least two years of related laboratory experience, or a high school diploma with at least 6 years of relevant laboratory experience.
Technical Competencies
Awareness of applicable guidelines and regulations appropriate for primary department, these may include USP, ISO, CTFA, FSA, ICH, EP, and/or JP.
Knowledge of metric system, scientific applications, experimental design, and data evaluation.
Can draft technical documents and communications (SOPs, protocols, Trackwise records).
Proficient at applicable NAMSA systems (LIMS, Trackwise, MasterControl, etc.) as appropriate per primary department.
Ability to work in GMP/GLP environment.
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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