QA Auditor III - Client Audit Host
About The Position
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. The QA Auditor III - Client Audit Host provides broad expertise to the department in one or more specialized areas or processes in the execution of the Quality Management System (QMS). This role involves leading and attending inter-departmental meetings related to their area of expertise to develop strategies and implementation plans. The Quality Assurance Specialist II serves as a client contact for company-contracted services for large or significant programs and contributes to policy-making decisions as a resource in their area(s) of expertise.
Requirements
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
- 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.
Nice To Haves
- 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.
Responsibilities
- Serve as subject matter expert for process/vendor audits or activities in several areas of expertise, e.g. review computer system validation data, lab investigations, root cause analysis, batch record review or total Quality Management.
- Represent the department in client and regulatory inspections/audits, and lead in development, lifecycle tracking, and effectiveness measurement of corrective actions.
- Provide training for department and/or laboratory staff.
- May lead risk assessments.
- Manage set up and filing of documents.
- May mentor junior team members in area(s) of expertise.
- Leads client and regulatory inspections. May lead vendor and internal audits, participate in client and regulatory inspections, and/or manage the administration and reporting aspects of quality management systems.
- Provides comprehensive expertise to the department covering one or more specialized quality management areas assuring all systems, processes and their outcomes comply with applicable international and national regulations
- Guidelines and fulfill client and company requirements
- Serves as quality consultant to the organization in their area(s) of GxP expertise
- Acting as a resource for training activities and policy-making decisions, supporting business leaders in mitigation of risk Being responsible for building relationships between on-site QA services and QA management of designated clients.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
