Principal Lab Tech In Vitro

NAMSA•Northwood, OH

3d•Onsite

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.

Requirements

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.
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.

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.