QA Auditor II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

This is a fully onsite role supporting our BIOA Lab in Richmond, VA. We welcome applicants from all locations within the US. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening.

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Discover Impactful Work:

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 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 meetingsEducation 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 travelWorking 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…