Lifelancer — өмір туралы ғылымдар, фармацевтика және IT салаларына бағытталған, жасанды интеллектпен жұмыс істейтін кадрларды жалдау платформасы. Ол білікті мамандарға өз тәжірибесін таныстыруға, халықаралық жұмыс пен жоба мүмкіндіктерін іздеуге және арнайы білімі бар мамандарды іздейтін жұмыс берушілермен байланысуға көмектеседі. Жұмысқа қабылдау топтары үшін Lifelancer жасанды интеллект көмегімен мамандарды іздеуді бірнеше елде жұмысқа қабылдау және еңбекақы төлеу үдерістерін қолдаумен біріктіреді, соның ішінде талаптарға сәйкестікке қатысты мәселелер де бар.
Remote RDQA Clinical Quality Auditor — New Jersey
Conduct GCP audits and corrective-action follow-up for AbbVie, supporting clinical quality and compliance across global operations. Advise business partners on clinical regulations, quality systems, and inspection readiness.
Сипаттама
- Manage the Clinical audit program, including scheduling, planning, reporting, and audit resolution.
- Maintain alignment with RDQA policies and procedures.
- Help develop and implement the Clinical QA quality system.
- Advise business partners on GCP and clinical quality matters.
- Assess clinical processes through audits and quality-assurance oversight to verify compliance.
- Lead and support the scheduling, planning, and execution of Clinical audits.
- Perform investigator site, process, system, and Affiliate audits.
- Deliver oral and written audit results within established timelines.
- Review and approve Corrective Action Plans and monitor actions through completion.
- Help develop and implement systems and processes that support global quality-assurance requirements.
- Support the maintenance and development of quality standards for Clinical audits.
- Participate in continuous-improvement initiatives and projects.
- Support GCP inspections as needed.
- Provide GCP regulatory guidance and consultation to RDQA and business partners.
- Encourage ongoing education in quality, clinical guidelines, and regulations.
Талаптар
- Bachelor’s degree in a physical, life, or health science; a healthcare profession such as nursing or pharmacy; or equivalent experience.
- Three to five years of experience in the biopharmaceutical industry or with a regulatory authority.
- Three to five years of experience in Quality Assurance and/or Clinical Research Development.
- Strong analytical ability and skill in drawing conclusions from presented data.
- Capacity to work effectively and efficiently in a dynamic environment with minimal supervision.
- Working awareness of clinical-trial regulations, including ICH-GCP and the EU Clinical Trial Directive/Regulation, as well as industry best practices.
- Flexibility to adapt to changing assignments and prioritize work effectively.
- Strong project-management, interpersonal, and communication skills.
- Ability to work independently and collaboratively within a team.
- Willingness and ability to travel internationally.
- Availability for travel of up to 40%.
- Equivalent experience may be accepted in place of the stated bachelor’s degree.
Артықшылықтар
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance.
- 401(k) plan.
- Short-term incentive programs.
- Equal-opportunity employer benefits and reasonable-accommodation support for eligible applicants.