Senior Lab Technician - Sterility Assurance

North American Science Associates•Irvine, CA

2d•$28

About The Position

NAMSA pioneered the industry and 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 with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas. Job Description: May perform various testing independently in accordance with SOPs and utilizing applicable work instructions, standards or guidelines. Performs routine calculations and may participate in analyzing and interpreting results. Maintain all test equipment and supplies for various testing Clean glassware and prepare reagents for use in laboratory testing. Perform routine disposal of laboratory waste including disposal of test articles. Assist with making solutions and preparing reagents. Assist in the preparation of items for testing. Monitor raw materials and final finished media for conformance with applicable material specifications and SOPs. May be responsible for extractions, which may include: test article and control preparation, animal holding and preparation and solution preparation. May be responsible for chain of custody, delivery of samples, filing and sample distribution/shipping. Accurately collect and record raw data in logbooks and on worksheets. Maintain clean workspace, testing supplies, and equipment May be responsible for checking laboratory equipment, being on-call and respond to continuous monitoring alarms as applicable and in accordance with criteria outlined in Standard Operating Procedures. May be required to operate specified laboratory equipment as applicable. Maintains an efficient workflow process relative to sample prioritization. Other duties as assigned. Qualifications & Technical Competencies: Principal Duties and Responsibilities Schedules and oversees daily operations of assigned laboratory area. Monitors work, coordinates resources, and communicates with other functional areas within NAMSA to address client expectations. May perform various testing independently in accordance with SOPs and utilizing applicable work instructions, standards or guidelines. Performs routine calculations and may participate in analyzing and interpreting results. Maintains all test equipment and supplies for various testing and may assist with procurement of test equipment. Clean glassware and prepare reagents for use in laboratory testing. Perform routine disposal of laboratory waste including disposal of test articles. Assist with making solutions and preparing reagents. Assist in the preparation of items for testing. May have direct client contact as needed. Monitors raw materials and final finished media for conformance with applicable material specifications and SOPs and resolve issues and non-conformances. May be responsible for extractions, test article and control preparation, animal holding and preparation and solution preparation. May be responsible for chain of custody, delivery of samples, filing and sample distribution/shipping. Accurately collect and record raw data in logbooks and on worksheets. Maintain clean workspace, testing supplies, and equipment May be responsible for checking laboratory equipment, being on-call and respond to continuous monitoring alarms in accordance with criteria outlined in Standard Operating Procedures. May be required to operate autoclave, depyrogenation oven or other specified laboratory equipment as applicable. Other duties as assigned.

Requirements

High School diploma or equivalent required and at least 4 years of experience, or Bachelor degree and 1 year of experience.
Sound judgment with effective decision making skills and the ability to solve problems or escalate as needed
Awareness of applicable guidelines and regulations including, but not limited to USP, ISO, CTFA, FSA.
Knowledge of metric system, NAMSA GLP and/or GMP testing, scientific applications, experimental design, and data evaluation.
Ability to work in GLP/GMP environment.

Responsibilities

May perform various testing independently in accordance with SOPs and utilizing applicable work instructions, standards or guidelines.
Performs routine calculations and may participate in analyzing and interpreting results.
Maintain all test equipment and supplies for various testing
Clean glassware and prepare reagents for use in laboratory testing.
Perform routine disposal of laboratory waste including disposal of test articles.
Assist with making solutions and preparing reagents.
Assist in the preparation of items for testing.
Monitor raw materials and final finished media for conformance with applicable material specifications and SOPs.
May be responsible for extractions, which may include: test article and control preparation, animal holding and preparation and solution preparation.
May be responsible for chain of custody, delivery of samples, filing and sample distribution/shipping.
Accurately collect and record raw data in logbooks and on worksheets.
Maintain clean workspace, testing supplies, and equipment
May be responsible for checking laboratory equipment, being on-call and respond to continuous monitoring alarms as applicable and in accordance with criteria outlined in Standard Operating Procedures.
May be required to operate specified laboratory equipment as applicable.
Maintains an efficient workflow process relative to sample prioritization.
Schedules and oversees daily operations of assigned laboratory area.
Monitors work, coordinates resources, and communicates with other functional areas within NAMSA to address client expectations.
Maintains all test equipment and supplies for various testing and may assist with procurement of test equipment.
May have direct client contact as needed.
Monitors raw materials and final finished media for conformance with applicable material specifications and SOPs and resolve issues and non-conformances.
May be required to operate autoclave, depyrogenation oven or other specified laboratory equipment as applicable.
Other duties as assigned.