**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** 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. **Location/Division Specific Information** This position is site-based in Bethesda, Maryland. Ideal candidates will possess experience with infectious disease in a containment laboratory environment. **Discover** **Impactful** **Work:** Conducts complex internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. Identifies issues impacting quality and/or regulatory compliance, supports determination of root cause of nonconformance and assists in developing strategies to address issues. May perform technical document review and other GxP activities in support of project work or company process. Provides finished audit reports to management. Plans and delivers billable quality services for clients and projects. **A day in the Life:** + Conducts and/or leads avarietyof client, internal or GxPauditsand regulatory inspections as requested by senior management + Performs directedsiteaudits, facility, vendor and/or sub-contractor audits + Provides GxP consultation and support to project teams and external clients + Leads process audits and may participate as a co-auditor in more complex system audits + Performs other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, processimprovement) + Serves as a knowledgeable 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 **Keys to Success:** **Education** Bachelor's degree or equivalent and relevant formal academic / vocational qualification **Experience** 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, Abilities** + Thorough knowledge of GxP and appropriate regional research regulations and guidelines + Demonstratedproficiency and led arangeof project based or internal GxPauditsand vendor audits to high standards required by management + Excellent oral and written communication skills + Strongproblemsolving, risk assessment and impact analysis abilities + Solid experience in root cause analysis + Above average negotiation and conflictmanagementskills + Flexible and able to multi-task and prioritizecompeting 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 **Physical Requirements / Work 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. + Ability to work in an upright and /or stationary position for 6-8 hours per day. + Repetitive hand movement of both hands withtheabilityto 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 avarietyof computer software developed both in-house and off-the-shelf. + Abilitytocommunicateinformationandideas so others will understand; withtheabilityto listen to and understand informationandideas presented through spoken words and sentences. + Frequently interacts withothers 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. **Benefits** We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! **Compensation and Benefits** The salary pay range estimated for this position Quality Specialist II based inMaryland 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 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.