GCP QA Auditor II- fully remote!

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Job Description

Thermo Fisher Scientific Inc. is a premier company that is dedicated to enabling our customers to make the world healthier, cleaner, and safer. We are a team of 100,000+ colleagues who share a common set of values - Integrity, Intensity, Innovation, and Involvement. Together, we work to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.

What will you do in this role?

Conduct complex internal and external Clinical Research Site audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines, and client contractual obligations. Identify issues impacting the quality and/or integrity of clinical research programs, determine root cause of non-conformance and develops strategies to address issues. Perform technical document review and other GCP practice activities in support of clinical development programs. Provide audit reports to management. Plan and deliver quality services including contracted quality assurance audits, internal site audits, laboratory and file audits for clients and projects. Lead process/quality improvement initiatives. Mentor peers. Develop tools and other materials for tracking of compliance management activities and analyze trends. Upon request, support regulatory inspections and/or client audit hosting.

Qualifications:

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous Clinical Site Auditing experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years) or equivalent combination of education, training, & experience.

Must have GCP and auditing experience for clinical trials, in order to qualify for this role!

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and Abilities:

• Thorough knowledge of applicable GCP and appropriate regional regulations. Other GCP knowledge is a plus.

• Strong knowledge of the clinical trial process

• Experience with study-specific (investigator site) audits or other GP audits, could also include process and vendor audits

• Experience in root cause analysis and CAPA development

• Well-rounded knowledge of SOPs and WIs

• Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)

• Strong attention to detail

• Effectively works independently or in a team environment

• Strong problem-solving skills, risk assessment and impact analysis abilities

• Above average negotiation and conflict management skills

• Flexible and able to multitask and prioritize competing demands/workload

• Strong computer skills; ability to learn and become proficient with appropriate software

• Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

The following experience is a plus:

• Hosting client audits and/or regulatory inspections.

• Auditing database, eTMF, and Clinical Study Report

• Training/mentoring of peers

Travel:

This role has 50% travel.

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 (bolded) 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 (bolded) 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 salary range estimated for this position based in Texas is -.

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

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