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описание
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
задачи
Join us as Senior Quality Assurance Specialist - And lead the efforts to maintain and enhance the quality and compliance of our clinical research programs.
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.
требования
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.
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
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.
условия
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
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.
