Associate Compliance Specialist - Quality Event Management

Yesterday

Apply Now

Receive Emails with Similar Jobs

Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+

Description

• Supports and implements quality and compliance processes. • Facilitates the tracking and reporting of activities and tasks. • Maintains tools and materials, and offers expertise to advance the vision of the department. • Researches and addresses issues using problem solving methodology, documents in accordance with ALCOA principals and metric compliance related to quality activities. • Knowledgeable of quality processes and ensures appropriate execution and completion. • Participates in small to medium-scale process improvement initiatives. • Communicates with representatives from other departments to ensure quality and timelines are maintained with respect to compliance activities (e.g., client audits, CAPA and/or procedural documents). • Develops support materials, presentations, and/or tools to support department's remit and strategies. • Works on problems of diverse scope with subject matter input, appropriate management of data, requires good problem solving skills. • Experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years) • Effective oral and written communication skills to support communication in English • Strong prioritization and time-management skills • Knowledge of the clinical trial process • Knowledge and understanding of ICH GCP and other relevant regulations and guidelines • Shown problem solving skills, including root cause analysis, corrective/preventive action(s) and effectiveness checks • Strong attention to detail • Strong computer skills; ability to learn and become proficient with appropriate software • Demonstrated ability to prioritize tasks for efficient workload management • Shown flexibility and adaptability • Effective judgment, decision making, issue and risk management skills • Strong creative and critical thinking skills