Biocompatibility Research Associate

Description

POSITION SUMMARY

Responsible for: Executing biocompatibility studies under GLP requirements related to the safety of various medical device components. May include but not limited to evaluation of blood cell integrity, platelet function, ELISA/EIA analysis. Will be trained to utilize a variety of instrumentation, including but not limited to, hematology analyzers, platelet aggregometer, and microplate reader. Assist in validation of biocompatibility assays; collaboration with cross-function team for general development of GLP laboratory compliance program; support for other high priority studies using similar test methods as needed.

What would be the primary duties for this position?

-Execute biocompatibility studies under GLP requirements related to the safety of various medical device components. May include but not limited to evaluation of blood cell integrity, platelet function, ELISA/EIA analysis.

-Will be trained to utilize a variety of instrumentation, including but not limited to, hematology analyzers, platelet aggregometer, and microplate reader.

-Assist in validation of biocompatibility assays

-Collaboration with cross-functional team for general development of GLP laboratory compliance program

-Support for other high priority studies using similar test methods as needed.

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT.

1. Primarily responsible for laboratory testing using a variety of techniques and analytical instrumentation, which may include but not limited to: hematology analyzer, platelet aggregometer, coagulation analyzer, spectrophotometry, ELISA and EIA analysis.

2. Assist in laboratory studies and protocols with respect to study execution, issue resolution, data analysis, and data review. Types of studies include but not limited to: instrument and/or method validation, physiological evaluation of blood or blood components with new or current products and processes.

3. Routine quality control and maintenance of laboratory instrumentation for blood product/biohazard laboratory including but not limited to coagulation analyzer, hematology analyzer, platelet aggregometer. Accurately assess results for validity and conformance to specifications.

4. Accurately assess data/results for validity and conformance to specifications and regulations.

5. Employ appropriate techniques/methods to successfully and independently execute routine assignments within negotiated deadlines.

6. Identify alternative methods for improving existing lab processes.

7. Comply with all relevant QSR, GxP, and safety requirements related to R&D to ensure compliance in all research, data collection and reporting activities.

8. Additional responsibilities related to laboratory operations, including inventory, quality, and laboratory safety compliance may be required.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email ~~~ (~~~) for other accommodation options.