Lab Technologist - Analytical Services

NAMSA pioneered the industry, NAMSA 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 industrys premier provider. We provide support for clients during every step of the product development lifecycle and beyond.

Come and work for an organization whose:
Mission is to make a scientific contribution to every medical device in the world.
Culture is passionately committed to the partnership between one another and our clients to improve and save lives through a respectful, trusting, and collaborative environment.
Values have stood the test of time.
Above all else, conduct ourselves with integrity


Job Description:

For bio/analytical applications, performs a variety of laboratory techniques including sample weighing and recording, preparation of standard solutions, buffers, sample preparation requiring homogenization, liquid-liquid extraction, filtration, centrifugation and pipetting, etc.
Validates bio/analytical methods and protocols adhering to GLP guidelines.
May perform routine test article/product preparation according to work instructions.
Assure testing/test article preparation/product is performed within due dates.
May prepare and maintain reagents and/or test articles as required for testing.
Performs the extraction process on prepared samples as directed by study protocol for analytical data generation.
Maintains an efficient and clean work area by receiving laboratory supplies, organizing and restocking as needed. Maintains logs as necessary for chemical receipt. Maintain relevant supplies and equipment used in routine testing.
Communicate well with clients, management and other NAMSA Associates to provide test schedule updates.
Operates, cleans and maintains incubators, autoclaves, hoods and other equipment routinely utilized.
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.
May communicate test schedule updates to NAMSA management as needed
Other duties as assigned.


Qualifications & Technical Competencies:



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

Bachelors 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.


Working Conditions

Physical activities include standing, walking, sitting, using hands to finger, handle, or feel, and reaching with hands and arms. Occasionally required to climb or balance.
Vision abilities required include close vision, color vision, depth perception, and ability to adjust focus.
Physical requirements include frequently lifting up to 25 pounds or more on occasion.
Employee must be able to talk and hear.

Working Conditions:


While performing the duties of this job, the employee is occasionally exposed to sharps and hazardous or caustic chemicals. The noise level in the work environment is usually moderate. Eye protection is required in designated areas and when performing specific tasks. The employee is occasionally exposed to small laboratory animals and may, on rare occasions, be exposed to blood borne pathogens and zoonotic diseases.
While performing the duties of this job, the employee is regularly required to stand, walk, reach with hands and arms, use hands to finger, handle or feel objects, tools or controls; talk and hear. The employee is occasionally required to sit, climb or balance, and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. The employee may be required to view computer monitors and stand for extended periods of time.