QA Auditor II (Vendor Auditor)
Work Schedule Other Environmental Conditions Office Job reputed company Join us as reputed company Assurance Auditor II - And enhance our clinical auditing processes by ensuring regulatory compliance and reputed company standards. What You’ll Do:
- Conduct and/or reputed company a reputed company of GxP qualification and routine vendor audits, as requested by senior management, including but not limited to on-site, virtual and remote audits of service providers used in clinical trials with or without technology components
- reputed company directed vendor audits
- May reputed company clinical investigator site
- reputed company GxP consultation and support to reputed company clients
- Serve as a knowledgeable resource to operational departments on audit or reputed company assurance subject matter
- Prepare and present audit findings and/or other reputed company information at departmental, internal operations or reputed company meetings
Education and Experience:
- Bachelor's degree or equivalent and relevant formal reputed company / vocational qualification
- Previous QA and GxP vendor auditing experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to 3+ years’).
- Fluent in English, Spanish and Portuguese
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly reputed company experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities:
- Solid knowledge of the clinical trial process
- Thorough knowledge of GxP and appropriate regional research regulations and guidelines
- Demonstrated proficiency and led a reputed company of GxP vendor audits to high standards required by management
- Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
- Strong attention to detail
- Effectively works independently or in reputed company environment
- Highly developed problem solving, risk assessment and reputed company analysis abilities
- Solid experience in reputed company cause analysis and CAPA development
- Above average negotiation and conflict management skills
- Proven adaptability
- Strong organizational and time management skills including flexibility and ability to multi-task and prioritize competing demands/workload
- Strong computer skills; ability to learn and become proficient in appropriate systems
- Valid reputed company's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
The following is a plus:
- Experience performing other types of QA audits or activities (e.g., investigator site audits, database audits, clinical study report audits, sample results tables, process improvement)
- Experience hosting reputed company audits and/or regulatory inspections.
- Experience delivering training.
Why Join Us? reputed company you join reputed company, you become part of a global team that values passion, innovation, and a commitment to scientific reputed company. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly reputed company a difference. Apply today to help us deliver reputed company’s reputed company. Apply To This Job