QA Auditor I

Regulatory Jobs; Richmond (VA); On-site; USD 32,000 - 41,000; Full time

Benefits offered by this job

Medical & dental plans

Vision plan

PTO & holidays

Parental leave

401(k) retirement plan

ESPP

Job summary

Thermo Fisher Scientific in Richmond, VA is seeking a QA Auditor I to support compliance and quality across GxP audits in a fully onsite role at our BIOA Laboratory. You will conduct routine audits, assist with non-complex process audits, and help prepare audit findings while collaborating with cross-functional teams to uphold regulatory standards.

The ideal candidate has a Bachelor’s degree or equivalent, some lab/QA experience, and knowledge of GxP/SOPs. Vaccine/Immunology experience is a plus.

Qualifications

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification; Associate degree and relevant experience is acceptable in lieu of bachelor’s degree.
• Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year).
• Vaccine, Immunology, or Molecular experience is a plus.

Responsibilities

• Conduct routine client, internal or GxP audits
• Assist or may conduct non-complex process audits
• Perform other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, facility audits, process improvement)
• Serve as a resource to operational departments on audit or quality assurance subject matter
• Assist in the preparation of audit findings and/or other related information

Skills

GxP knowledge

SOP knowledge

Communication skills

Attention to detail

Independent work

Problem solving

Organization & time management

Computer literacy

Driver's license

Education

Bachelor's degree or equivalent

Associate degree with relevant experience acceptable

Job description

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

Position

QA Auditor I

Location

Richmond, VA

Department

Quality Assurance

This is a fully onsite role based at our BIOA Laboratory in Richmond, VA. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.

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 innovation.

As a Quality Assurance Auditor I and play a crucial role in ensuring compliance and excellence in our clinical auditing processes.

What You’ll Do:

• Conduct a variety of routine client, internal or GxP audits
• Assist or may conduct non-complex process audits
• Perform other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, facility audits, process improvement)
• Serve as a resource to operational departments on audit or quality assurance subject matter
• Assist in the preparation of audit findings and/or other related information

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification; Associate degree and relevant experience is acceptable in lieu of bachelor’s degree.
• Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year).
• Vaccine, Immunology, or Molecular experience is a plus.

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:

• Introductory knowledge of applicable GxP and appropriate regional regulations
• Working knowledge of SOPs
• Strong oral and written communication skills (including appropriate use of medical and scientific terminology)
• Good attention to detail
• Able to work independently or in a team environment
• Good problem-solving abilities
• Good organizational and time management skills
• Basic computer skills and ability to learn and become proficient with appropriate software
• Proven flexibility and adaptability
• Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

Thermo Fisher values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

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.

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

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.

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.

Compensation and Benefits

The hourly pay range estimated for this position based in Virginia is $23.00-30.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount