Laboratory Support Specialist

5 days ago

Irvine, United States American Preclinical Services Full time

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**:

- 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

**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
- 2+ years with Bachelor's degree or 6+ years with HS diploma

Salary Range: $26.00- $30.00

Working Conditions:

- Physical activities include sitting, walking, and standing for prolonged periods and operate laboratory equipment.
- Extensive use of computer keyboard and mouse.

Pay Range Minimum:
$21.25

Pay Range Target:
$28.00

Pay Frequency:
Hourly
- 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._

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