myGwork - LGBTQ+ Business Community · 3 days ago

QA Auditor Level II and III

United States

Full-time

Remote

Mid, Senior Level

5+ years exp

Wonder how qualified you are to the job?

Maximize your interview chances

Internet

Insider Connection @myGwork - LGBTQ+ Business Community

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

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

Provides GCP 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

Act as a lead for client with billable audits

Provides mentorship and guidance to junior auditors

This role will have a travel requirement of up to 50%.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

QA ExperienceGCP KnowledgeResearch Regulations KnowledgeProject AuditsVendor AuditsRoot Cause AnalysisRisk AssessmentImpact AnalysisCorporate Credit CardProblem SolvingCommunicationNegotiationConflict ManagementFlexibilityMulti-taskingPrioritizationGxP Experience

Required

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

Thorough knowledge of GCP and appropriate regional research regulations and guidelines

Demonstrated proficiency and led a range of project based or internal GCP 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