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 InformationThis 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 a variety of client, internal or GxP audits and regulatory inspections as requested by senior managementPerforms directed site audits, facility, vendor and/or sub-contractor auditsProvides GxP consultation and support to project teams and external clientsLeads process audits and may participate as a co-auditor in more complex system auditsPerforms other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement)Serves as a knowledgeable resource to operational departments on audit or quality assurance subject matterPrepares and presents audit findings and/or other related information at departmental, internal operations or client meetingsKeys to Success: EducationBachelor's degree or equivalent and relevant formal academic / vocational qualification ExperiencePrevious 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, AbilitiesThorough knowledge of GxP and appropriate regional research regulations and guidelinesDemonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by managementExcellent oral and written communication skillsStrong problem solving, risk assessment and impact analysis abilitiesSolid experience in root cause analysisAbove average negotiation and conflict management skillsFlexible and able to multi-task and prioritize competing demands/work loadValid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travelPhysical 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 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.BenefitsWe 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