QA Auditor III to QA Manager

ThermoFisher Scientific; España; On-site; PHP 450,000 - 750,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Quality Assurance Auditor to strengthen our clinical auditing processes and ensure regulatory compliance and quality standards across projects. You will conduct and lead GxP audits, provide compliance guidance to project teams and clients, and act as a trusted resource for operations, vendors and sub-contractors in a controlled office/lab environment.

With a Bachelor’s degree and 2+ years of QA experience, you’ll bring strong analytical, communication and

Qualifications

• GxP knowledge and familiarity with regional regulations.
• Experience conducting internal or external audits and inspections.
• Strong communication and analytical abilities.
• Ability to lead audits and interact with cross-functional teams.

Responsibilities

• Conduct or lead client, internal or regulatory audits and inspections.
• Perform site, facility, vendor and subcontractor audits as directed.
• Provide GxP consultation and support to project teams and clients.
• Lead process audits and participate as a co-auditor on complex systems.
• Prepare and present audit findings to departments or clients.

Skills

GxP knowledge

Audit leadership

Regulatory compliance

Communication skills

Problem solving

Root cause analysis

Negotiation skills

Multitasking

Travel readiness

Education

Bachelor's degree or equivalent

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join us as Quality Assurance Auditor and enhance our clinical auditing processes by ensuring regulatory compliance and quality standards.

What You’ll Do:

• Conduct and/or lead a variety of client, internal or GxP audits and regulatory inspections as requested by senior management
• Perform directed site audits, facility, vendor and/or sub-contractor audits
• Provide GxP consultation and support to project teams and external clients
• Lead process audits and may participate as a co-auditor in more complex system audits
• Perform other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement)
• Serve as a knowledgeable resource to operational departments on audit or quality assurance subject matter
• Prepare and present audit findings and/or other related information at departmental, internal operations or client meetings

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ 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:

• Thorough knowledge of GxP and appropriate regional research regulations and guidelines
• Demonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by management
• Excellent oral and written communication skills
• Strong problem solving, risk assessment and impact analysis abilities
• Solid experience in root cause analysis
• Above average negotiation and conflict management skills
• Flexible and able to multi-task and prioritize competing demands/work load
• 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 a clinical environment.
• 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.

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 15-20 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 multi-task.
• 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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.