IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
We are always looking for new talent to join Q2 Solutions. To be considered for a future Quality Assurance Auditor position, submit your resume. If your qualifications, experience, and skill sets align with the position requirements, one of our recruiters will connect with you.
Plan, conduct and report results of independent audits to assess compliance with regulations, guidelines, operating procedures and policies. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Provide quality assurance oversight under through interaction with customers, project and study teams and associated business functions.
Conduct audits of regulated bioanalytical analyses in support of clinical and nonclinical studies to assess compliance with applicable Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) regulations/guidelines, customer requirements, Q2 Solutions’ SOPs and project specific guidelines/instructions.
Lead study and process inspections of critical bioanalytical phases of non-clinical and clinical studies.
Conduct quality assurance activities and projects for clients according to policies and procedures within budget and established timelines.
Assist in the preparation and review of corrective action plans.
Represent QA on customer and project teams
Document and report quality and compliance issues to QA management according to required timelines.
Advise QA management on system audit needs.
Assist in hosting customer audits and regulatory inspections
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Working knowledge of pharmaceutical research and development processes and regulatory requirements especially as they relate to laboratory environments
Considerable knowledge of GXP regulations and quality assurance processes and procedures.
Demonstrated communication and interpersonal skills.
Effective problem solving skills.
Effective organization, communication, and team orientation skills.
Ability to initiate assigned tasks and to work independently.
Ability to manage multiple projects and complete assigned audit tasks in a timely fashion in a high-throughput laboratory environment
Ability to establish and maintain effective working relationships with coworkers, managers and clients
Knowledge of word-processing, spreadsheet, and database applications.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s/primary degree, preferably in a science or engineering field
3 years experience in pharmaceutical, technical, or related area including GXP and/or Quality Assurance; or equivalent combination of education, training and experience
Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time
Position requires extensive use of telephone and face-to-face communications, which requires the accurate perception of speech
Some travel required, may include international travel.
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled