Clinical Quality Assurance Specialist at Thermo Fisher Scientific in Highland Heights, Kentucky

Job Description:

Work Schedule

Standard (Mon-Fri)



Environmental Conditions

Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)



Job Description



At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.



Location/Division Specific Information



Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.



Division/ Dept.: Clinical Research Group/ Global Central Labs




Location: Hybrid (Local to the Highland Heights, KY area)




Summarized Purpose:


At Thermo Fisher Scientific, we offer an outstanding opportunity for a Quality Assurance Specialist to join our ambitious Research team. This role is pivotal in ensuring the flawless execution of our world-class scientific projects. Your contributions will determine the success and reliability of our research endeavors, ultimately helping to craft the future of science.



A day in the life:

• Conduct detailed audits to identify and address any areas of non-compliance


• Act as host of client audits and regulatory inspections


• Collaborate with cross-functional teams to successfully implement corrective actions


• Maintain comprehensive documentation of all quality assurance activities


• Train and support staff on quality assurance processes and standard methodologies as needed


• Continuously improve our quality assurance systems to meet evolving industry standards

Education:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Experience:

• Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.




Knowledge, Skills and Abilities:

• Experience in a Quality Assurance role within the scientific research industry is an advantage


• Knowledge of industry standards and regulatory requirements or willing to learn


• Strong analytical and problem-solving abilities


• Excellent attention to detail and the ability to strictly enforce compliance


• Strong communication and collaboration skills


• Ability to work independently and as part of a team


• A dedication to continuous improvement and lifelong learning

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.


• Able to work upright and stationary for typical working hours.


• Ability to use and learn standard office equipment and technology with proficiency.


• May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.


• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.


• May require travel. (Recruiter will provide more details.)

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