QA Auditor I

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 I - And play a crucial role in ensuring compliance and excellence in our clinical auditing processes.

What You’ll Do:

• Conducts a variety of client, internal or GxP audits and supports regulatory inspections as requested by senior management
• Participates in process audits
• Performs other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, facility audits, process improvement)
• Serves as a resource to operational departments on audit or quality assurance subject matter
• Prepares and presents 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 1-2 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:

• Familiar with applicable GxP and appropriate regional regulations
• Demonstrated ability to perform GxP audits based on SOPs and applicable FDA regulations, ICH guidelines and to all other standards or guidelines applicable to business-related requirements,
• Demonstrated ability to independently review study documents for compliance with regulatory requirements or organization's procedures (e.g. Informed consents, protocols, CRFs, Source Document Templates, method validations, equipment qualifications)
• Achieves acceptable standards of quality and meets timelines for QA deliverables and required departmental reports
• Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
• Very good problem solving, risk assessment and impact analysis abilities
• Proficient at negotiation and conflict management
• Flexible and able to multi-task and prioritize competing demands/workload
• 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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

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.

Accessibility/Disability Access

• Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

  *This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.