The posting
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
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.
