Compliance Specialist- remote on the East Coast!

North Carolina, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Pharmaceutical Services, Scientific ResearchIndustries

Requirements

A Bachelor's degree or equivalent qualification is required, along with at least 2 years of relevant experience. A minimum of 1 year of client audit and/or regulatory inspection hosting experience is necessary, as is client hosting experience. Strong proactive communication skills, excellent oral and written communication, strong organizational and time-management skills, extensive knowledge of the clinical trial process, comprehensive knowledge of ICH GCP and relevant regulations, demonstrated problem-solving skills, excellent attention to detail, strong computer skills, and the ability to multitask and adapt are all essential.

Responsibilities

The Compliance Specialist will host client audits, research and address issues, track metrics, and maintain documentation for quality and compliance activities. They will lead quality and compliance processes, ensure their execution, and lead smaller projects or process improvement initiatives. This role involves communicating with other departments to maintain quality and timelines for compliance activities and mentoring staff, serving as a team lead for group projects or process improvement initiatives.

Skills

Compliance

Quality Assurance

Auditing

Reporting

Documentation

Process Improvement

CAPA

Client Communication

Mentoring

Team Leadership

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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