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By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice an…
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice an…
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Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our coll…
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Full-time
bachelor degree
Posted 30d ago
~40 hrs/week
Responsibilities
Conduct and lead various GxP, internal, and vendor audits to ensure regulatory compliance and quality standards. Provide expert consultation to project teams and present audit findings to internal and external stakeholders.
Requirements
Requires a bachelor's degree or equivalent with at least 2 years of relevant quality assurance experience. Must possess thorough knowledge of GxP regulations and strong problem-solving and communication skills.
Full job description
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join us as Quality Assurance Auditor II - And enhance our clinical auditing processes by ensuring regulatory compliance and quality standards.
What You’ll Do: • Conduct and/or lead a variety of client, internal or GxP audits and regulatory inspections as requested by senior management • Perform directed site audits, facility, vendor and/or sub-contractor audits • Provide GxP consultation and support to project teams and external clients • Lead process audits and may participate as a co-auditor in more complex system audits • Perform other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement) • Serve as a knowledgeable resource to operational departments on audit or quality assurance subject matter • Prepare and present 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 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: • Thorough knowledge of GxP and appropriate regional research regulations and guidelines • Demonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by management • Excellent oral and written communication skills • Strong problem solving, risk assessment and impact analysis abilities • Solid experience in root cause analysis • Above average negotiation and conflict management skills • Flexible and able to multi-task and prioritize competing 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
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.
Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.
Apply today to help us deliver tomorrow’s breakthrough.
Related keywords
GxPQuality AssuranceClinical AuditingRegulatory InspectionsVendor AuditsRoot Cause AnalysisRisk AssessmentComplianceClinical Study Report AuditsDatabase AuditsThermo Fisher ScientificLife SciencesPharmaceutical Services
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
For more information, please visit www.thermofisher.com.
Offices: 168 Third Avenue, Waltham, MA, US
Analytical InstrumentsLaboratory Supply Chain Programs and eCommerceLaboratory EquipmentLab ServicesSpecialty DiagnosticsLife SciencesPharma Servicesand CDMOElectronicsHealth Care
How many Healthcare jobs are open in Suzhou, China right now?
There are currently 67 open healthcare positions in Suzhou, China listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Suzhou, China?
Companies currently hiring include Johnson & Johnson Innovative Medicine, Thermo Fisher Scientific, Vantive, Roche, Stryker, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Suzhou, China?
Yes — 15 of the 67 open healthcare positions offer remote or hybrid work (4 remote, 11 hybrid).
How do I apply for Healthcare jobs in Suzhou, China?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.