Senior QA Specialist

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.