Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health. A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization's clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.
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.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at firstname.lastname@example.org to arrange for such an accommodation.
Job ID: R1101876