Laboratory Support Specialist (TSS)
American Preclinical Services
Irvine, California
technical
technical support
test
technical
laboratory
medical
data
coordinate
evaluation
p&r
technical review
pricing
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February 14, 2023
American Preclinical Services
Irvine, California
FULL_TIME
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 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 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:
- Perform technical review of incoming work to determine test appropriateness and sample requirement.
- Review incoming test articles, requested tests, and pricing in a timely and accurate fashion.
- Investigate and resolve discrepancies with test samples.
- Review and sign routine GMP reports for technical accuracy and completeness.
- Review raw data generated by laboratory studies for technical accuracy and completeness
- Make approved changes to documents (SOP’s, reports, protocols, worksheets).
- Coordinate the development of test specifications and test methods for routine test articles with laboratory staff.
- Supports lab with routine testing as well as evaluation testing for new or updated procedures.
- Confirm quality systems are applied in the performance and documentation of laboratory studies.
- May discuss routine testing programs with Clients
- Work with client to develop test specifications for routine testing.
- Other duties as assigned.
Qualifications & Technical Competencies:
Principal Duties and Responsibilities
Oversee and coordinate the development of test specifications and test methods for complex test articles with laboratory staff.
Perform technical review of incoming work to determine test appropriateness and sample requirement.
Review incoming test articles, requested tests, and pricing in a timely and accurate fashion.
Investigate and resolve discrepancies with test samples.
Work with client to develop test specifications for complex testing and provide technical support and direction to the client as needed.
Coordinate the development of test specifications and test methods for routine test articles with laboratory staff.
Review and sign routine GMP reports for technical accuracy and completeness.
Review raw data generated by laboratory studies for technical accuracy and completeness
Conduct high level laboratory testing investigations.
Make approved changes to documents (SOP’s, reports, protocols, worksheets).
Develops specialized departmental reports (eg. Environmental monitoring, water testing reports) including trend analysis where applicable.
Supports lab with routine testing as well as evaluation testing for new or updated procedures.
Confirm quality systems are applied in the performance and documentation of laboratory studies.
May discuss routine testing programs with Clients
Other duties as assigned.
Qualifications and Skills
Qualifications: 4+ years/degree or 8+ years/HS
Technical Competencies
Demonstrated knowledge of scientific applications, GLP regulations, experimental design, data evaluation, metric system, medical device testing, and technical writing.
Awareness of applicable guidelines and regulations such as USDA, USP, FHSA, CTFA, FDA, Tripartite, and ISO standards.
Working Conditions
Physical activities include sitting, walking, and standing for prolonged periods and operate laboratory equipment.
Extensive use of computer keyboard and mouse.
Working Conditions:
- Physical activities include sitting, walking, and standing for prolonged periods and operate laboratory equipment.
- Extensive use of computer keyboard and mouse.
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