Work Schedule

Environmental Conditions

Job Description

Join us as Senior Quality Assurance Specialist - And lead the efforts to maintain and enhance the quality and compliance of our clinical research programs.

What You’ll Do:
• Manage and lead all activities associated with client, regulatory, quality management system and/or internal audits and investigations to include coordination, scheduling, hosting, conduction of audits and review of audits responses.
• Verify compliance with SOPs/WPDs and contractual obligations for audit target selection and frequency of audits to ensure ongoing quality.
• Liaise with several internal departments and senior management to provide full internal oversight of the GxP/GDP services provided to clients and facilitate interaction across functional, regulatory and legal teams.
• Develop, update and disseminate SOPs/WPDs as they relate to quality processes.
• Perform internal and external audit related activities as needed and escalate significant issues appropriately. Continually ensures audit readiness of client files.
• Contribute to quality improvement activities to ensure the organization meets or exceeds client expectations for the implementation of quality management systems and processes.
• Ensure full compliance with internal procedures pertaining to quality investigations, quality audits and quality improvement initiatives.
• Provide mentorship and guidance to less experienced quality staff.
• Perform root cause analysis. Assist in resolving critical quality issues to include CAPAs, complaints and recalls, and resolves non-critical quality issues such as deviations.
• Generate reports to provide internal management with tracking, trending, informed analysis reports, process improvement data and key performance metrics.

Education and Experience:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous QA experience to provide the knowledge, skills, and abilities to perform the job (comparable to 8+ 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:
• Comprehensive expertise in all aspects of pharmaceutical GxP regulations (e.g. quality systems, root cause analysis and Total Quality Management) including international regulations
• Knowledge of applicable parts of 21 CFR regulations
• May require knowledge of ISO standards where applicable
• Expertise in GxP and appropriate regional clinical research regulations and guidelines
• Proven proficiency with leading a range of project based or internal GxP audits and vendor audits to high standards
• Superior oral and written communication skills
• Expert problem solving, risk assessment and impact analysis abilities
• In depth experience in root cause analysis
• Excellent negotiation and conflict management skills
• Ability to remain flexible, multitask, and prioritize competing demands
• Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

Working Conditions and Environment:
• Work is performed in an office, laboratory and/or GMP Depot environment.
• For laboratory positions, potential exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Variable work hours to accommodate schedules

Physical Requirements:
• Ability to work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of up to 50 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multitask.
• Regular and consistent attendance.

Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthrough.