Thermo Fisher Scientific is a world leader in serving science, offering innovative solutions to advance scientific research, healthcare, and clinical services. With a commitment to quality and compliance, Thermo Fisher ensures that its products and services meet the highest industry standards. The company operates globally, employing dedicated professionals who work passionately to make the world healthier, cleaner, and safer.
Thermo Fisher’s Quality and Regulatory teams focus on ensuring accuracy, safety, and effectiveness in all products and services. By joining their team, professionals get an opportunity to work on high-impact projects, grow their skills, and explore career development paths in a dynamic, collaborative environment.
Job Responsibilities
As an Associate Compliance Specialist, Quality Event Management, you will play a pivotal role in ensuring the smooth execution of quality and compliance processes. Your responsibilities will include:
- Process Management: Support and implement quality compliance processes in adherence to company standards.
- Tracking and Reporting: Facilitate accurate tracking of tasks and generate reports for key quality activities.
- Problem Solving: Identify and resolve issues using problem-solving methodologies, while maintaining compliance with ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate).
- Interdepartmental Coordination: Collaborate with various internal teams to ensure timelines and quality standards are met for client audits, CAPA (Corrective and Preventive Actions), and documentation.
- Process Improvements: Participate in small to medium-scale initiatives to improve operational efficiency.
- Support Development: Create presentations, tools, and materials to align with department strategies.
Qualifications and Education
The following qualifications are essential for the role:
- Academic Requirement: A Bachelor’s degree or an equivalent academic or vocational qualification.
- Work Experience: 0 to 2 years of experience in a related role. Relevant education, training, or experience will also be considered.
Skills and Abilities
The ideal candidate will possess the following skills:
- Communication Skills: Proficient in English (both written and verbal) for effective collaboration.
- Knowledge of Regulations: Familiarity with the clinical trial process, ICH GCP guidelines, and other regulatory standards.
- Problem Solving: Strong analytical skills, including root cause analysis and CAPA processes.
- Time Management: Ability to prioritize multiple tasks and manage time efficiently.
- Attention to Detail: High attention to detail for accurate documentation and quality management.
- Technical Skills: Comfortable using software tools and learning new platforms.
- Adaptability: Ability to remain flexible in changing work conditions.
- Decision-Making: Effective judgment and risk management capabilities.
