MedTech Lab Technologist — GMP/GLP Testing Expert

NAMSA

Northwood (OH)

On-site

USD 52,000 - 75,000

Full time

14 days+

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Job summary

NAMSA, a leading MedTech materials specialist, is seeking candidates for a laboratory role in Ohio. The position focuses on routine test article preparation and testing per NAMSA SOPs, with data analysis, recordkeeping, and adherence to GMP/GLP guidelines.

Ideal applicants will hold a Bachelor’s degree in a scientific field and have at least two years of related laboratory experience. The role involves environment monitoring, equipment maintenance, and potential autoclave operation in a

Qualifications

Bachelor’s degree in scientific discipline and at least two years of related laboratory experience.
Awareness of GMP/GLP guidelines and regulatory expectations.
Ability to draft technical documents and SOPs.
Proficient in data evaluation and basic statistics.
Experience with environmental monitoring and sterile testing is a plus.

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 positive results 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.
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.