Senior Microbiologist

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:

• Independently perform routine test article/product preparation and execute routine testing and perform routine calculations per NAMSA SOPs, and according to applicable work instructions. May be requested to conduct more involved studies.
• Oversee special studies including worksheet development, scheduling of testing and ordering a special/excess materials and seeking technical assistance to resolve questions during the study as needed.
• Design and conduct or coordinate feasibility and validation studies associated with test development efforts.
• Advise clients on testing/technical issues.
• Participate in analyzing and interpreting results. Assure proper records and sufficient data are maintained on all testing and the research information is presented in a logical methodical comprehensive conclusive and scientifically sound manner.
• Prepare or participate in the preparation of controlled documents (protocols, test specifications, SOP's, associated documents, etc.) in conjunction with the requirements of the applicable standards and/or client instructions.
• Develop a prioritized timeline for each test development effort; schedule and coordinate activities within and between appropriate departments and coordinate projects to meet goals established in agreed upon timelines.
• May be responsible for reviewing and overseeing assigned testing activities.
• Participate in the improvement of documents, test systems, quality systems and workflow.
• Accurately collects and records raw data in logbooks and on worksheets.
• Responsible for checking laboratory equipment, being on-call and respond to continuous monitoring alarms as applicable. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures.
• Perform required specific testing as applicable.
• Operate specified laboratory equipment as applicable.
• May perform Environmental Monitoring, clean and disinfect cleanroom suites (required as applicable).
• Other duties as assigned.

Qualifications & Technical Competencies:

Principal Duties and Responsibilities Independently perform routine test article/product preparation and execute routine testing and perform routine calculations per NAMSA SOPs, and according to applicable work instructions. May be requested to conduct more involved studies. Oversee special studies including worksheet development, scheduling of testing and ordering a special/excess materials and seeking technical assistance to resolve questions during the study as needed. Design and conduct or coordinate feasibility and validation studies associated with test development efforts. Advise clients on testing/technical issues. Participate in analyzing and interpreting results. Assure proper records and sufficient data are maintained on all testing and the research information is presented in a logical methodical comprehensive conclusive and scientifically sound manner. Prepare or participate in the preparation of controlled documents (protocols, test specifications, SOP's, associated documents, etc.) in conjunction with the requirements of the applicable standards and/or client instructions. Develop a prioritized timeline for each test development effort; schedule and coordinate activities within and between appropriate departments and coordinate projects to meet goals established in agreed upon timelines. May be responsible for reviewing and overseeing assigned testing activities. Participate in the improvement of documents, test systems, quality systems and workflow. Accurately collects and records raw data in logbooks and on worksheets. Responsible for checking laboratory equipment, being on-call and respond to continuous monitoring alarms as applicable. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures. 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 as applicable. Operate autoclave, depyrogenation oven or other specified laboratory equipment as applicable. Perform Kinetic-Chromogenic LAL testing as applicable. Perform Environmental Monitoring, clean and disinfect cleanroom suites as applicable. Other duties as assigned.

• Salary range: $90k- $110k
• Qualifications and Skills Bachelor degree and at least 8 years of experience Sound judgment with effective decision making skills and the ability to solve problems or escalate as needed Technical Competencies 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. Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires maintaining physical condition necessary for walking, standing, or sitting for prolonged periods of time. Extensive use of computer keyboard; operate computer equipment.

Working Conditions:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Requires maintaining physical condition necessary for walking, standing, or sitting for prolonged periods of time.
• Extensive use of computer keyboard; operate computer equipment.

Pay Range Minimum:

$66,800.00

Pay Range Target:

$110,000.00

Pay Frequency:

Annual Please Note:

Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills. NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.

Fair Chance Employment Statement:

At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history. Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position:

• May operate equipment
• Records data timely and accurately
• May analyze and interpret data
• Conducts studies on medical devices that have an impact on human life A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment.

We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.