Senior QA Specialist
Thermo Fisher Scientific · Zaventem
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.
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