Technologist, Quality Control Manufacturing - Irvine, CA at Geebo

Technologist, Quality Control

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
May perform routine test article/product preparation according to work instructions.
May execute routine testing per NAMSA SOPs, with appropriate data analysis.
May communicate test schedule updates to NAMSA management as needed.
May provide on the job training.
Assure testing/test article preparation/product is performed within due dates.
May prepare and maintain reagents and/or test articles as required for testing.
Maintain ancillary records (logbooks, worksheets).
Maintain relevant supplies and equipment used in routine testing.
Routes all positive results or unusual testing occurrences to management.
May order and/or stock supplies subject to approval.
May be responsible for checking laboratory equipment, being on-call and respond to continuous monitoring alarms. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures.
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, as required for specific testing.
May be required to operate autoclave.
Qualifications and Skills
Bachelor's degree in scientific discipline required or a high school diploma with at least 3 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.
Ability to work in a GLP/GMP environment.
Working knowledge of applicable NAMSA systems (LIMS, Trackwise, MasterControl, etc.) as appropriate per primary department.
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, 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.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.

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