QA Auditor II

Remote Worker LTD.; United States; Remote; USD 65,000 - 90,000; Full time

Job summary

Remote Worker LTD. is seeking a Quality Assurance Auditor II to strengthen regulatory compliance and QA processes. The role involves leading client, internal, and GCP audits, advising project teams, and presenting findings.

Office-based environment with opportunities to work across facilities and vendors; requires Bachelor's degree and 2+ years QA experience; travel for site audits may be required.

Qualifications

• Bachelor's degree is required or equivalent.
• 2+ years QA experience preferred.

Responsibilities

• Conduct and/or lead client, internal or GCP audits and regulatory inspections as requested by senior management.
• Perform directed site audits, facility, vendor and/or sub-contractor audits.
• Provide GCP consultation and support to project teams and external clients.
• 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.

Skills

GCP knowledge

Audit management

Communication

Problem solving

Root cause analysis

Negotiation

Multitasking

Driver's license

Education

Bachelor's degree

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Locations considered: UK, France or Spain

Join us as Quality Assurance Auditor II - 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 GCP audits and regulatory inspections as requested by senior management
• Perform directed site audits, facility, vendor and/or sub-contractor audits
• Provide GCP consultation and support to project teams and external clients
• 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’).

Knowledge, Skills and Abilities:

• Thorough knowledge of GCP and appropriate regional research regulations and guidelines
• Demonstrated proficiency and led a range of project based or internal 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.