Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As a QA Auditor, you will conduct internal and external GCP audits and process audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and client contractual obligations.

Summarized Purpose:

Conducts internal and external GCP internal and/or external audits and process audits verifying compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. Identifies issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues. May perform technical document review and other GxP practice activities in support of clinical development programs. Provides audit reports to management. Plans and delivers quality services for internal process audits and contracted quality assurance audits., internal site audits, laboratory and file audits for clients and projects.

*Essential Functions:   *

• Conducts and/or leads a variety of client, internal or GCP audits and process audits as requested by senior management

• Provides GCP/GxP consultation and support to PPD project teams and external clients Leads process audits and may participate as a co-auditor in more complex system audit.

• Performs other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement)

• Serves as a 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

• Provides mentorship and guidance to junior auditors

*Education and Experience: *

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

Previous QA experience in GCP area that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience. Previous experience in other GxP areas welcomed.

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 GCP / GxP and appropriate regional research regulations and guidelines

• Demonstrated proficiency and led a range of project based or internal GCP/GxP audits and vendor audits to high standards required by management

• Excellent oral and written communication skills

• Willingness to travel

• 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/workload

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

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.