Job Title: Biocompatibility SpecialistJob DescriptionAs a Biocompatibility Specialist, you will closely partner with manufacturing, engineering, and other functional groups on regulatory compliance issues, developing solutions to problems of moderate to intermediate complexity. Your role will involve supporting global regulatory submissions for medical devices and pharmaceutical products, providing essential chemistry support to global sites, and ensuring adherence to relevant quality system regulations and standards. You will oversee biocompatibility testing activities, interpret chemistry data during risk assessments, and maintain comprehensive documentation related to biocompatibility testing. Collaborate with internal departments to integrate biocompatibility requirements into product development processes and support the development and maintenance of Quality Management Systems. Additionally, you will provide training on biocompatibility testing requirements and support internal and external audit programs.Hard Skills
Regulatory compliance
Global regulatory submissions
Chemistry support
Quality system regulations adherence
Biocompatibility testing oversight
Documentation maintenance
Quality Management Systems development
Soft Skills
Problem-solving
Data interpretation
Risk assessment
Collaboration
Training and education
Job TypeThis is a Contract-to-Hire position with a duration of 6 Month(s).Work SiteThis is a fully on-site position in Lakewood, Colorado.Work EnvironmentYou will be part of a small, global team with about 5-6 associates, reporting directly to your supervisor. The role primarily involves reviewing data and working at a computer using LIMS. The position operates Monday to Friday. The first 30 days will focus on training on internal requirements, followed by taking on small projects or supplementary project needs with assistance.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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
Full-time