Global Auditor-Biotech/Life science

Company: BioIVT
Location: Winchester
Posted on: November 22, 2021

Job Description:

BioIVT is a leading global provider of high-quality biological specimens and value-added services. We specialize in control and disease state samples including human and animal tissues, cell products, blood, and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research and the effort to improve patient outcomes by coupling comprehensive clinical data with donor samples.Our Research Services team works collaboratively with clients to provide in vitro hepatic modeling solutions. And as the world's premier supplier of ADME-Tox model systems, including hepatocytes and subcellular fractions, BioIVT enables scientists to better understand the pharmacokinetics and drug metabolism of newly discovered compounds and their effects on disease processes. By combining our technical expertise, exceptional customer service, and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in ELEVATING SCIENCE -.This position is work at home-based, preferably close to one of our current office locations in the Eastern US, with the ability to travel to sites in the US and Internationally.The general auditor will work in the auditing of clinical sites and third-party suppliers conducting collections (both human and animal). Emphasis will be placed on ensuring the highest regulatory and ethical standards, but also focus on process improvement and issue mitigation.The primary focus of this position is to work with Global Quality & Regulatory Department to develop a global strategy for auditing and monitoring.The role:

• Work to develop a global auditing and monitoring plan for all participants.
• Coordinate auditing activities.
• Potential to build an auditing/monitoring team; Manage auditing/monitoring staff.
• Perform routine audits remotely and/or in person.
• Develop audit/monitoring specific SOPs, work instructions, etc.
• Create reports and maintain tracking.
• Advise the business on corrective and preventative action planning.
• Keeping customer and other stakeholder audits in mind, develop appropriate procedures to answer questions that arise.
• Work with internal QA/QC teams and others to ensure internal audits satisfy regulatory requirements.
• Conduct internal regulatory audits periodically, create associated reports and maintain tracking.
• Cross-functional training within the Regulatory department including working with team members currently entrusted with conducting auditing/monitoring.
• Performs all study-related matters in a cost-effective manner and in adherence to regulatory standards.
• Ability to maintain the confidentiality of information in compliance with company policies, IRB, FDA, USDA, and other local and foreign privacy regulations.
• Ability to travel as needed (Minimum Educational, Experience & Skill Requirements:
  • At least 3 years of applicable experience in the clinical research industry (5+ years preferred)
  • Minimum of bachelor's related to health care, research, or biotechnology, preferred.
  • Clinical research and/or clinical quality certification preferred i.e. CCRC, CRA, CQA, RAPS.
  • Knowledge in medical terminology both human and animal.
  • Working knowledge of US federal regulations related to clinical research studies, animal research (Animal Welfare Act), and USDA, IRBs, ICH Guidelines, and GCP.
  • Knowledge of international regulations as it relates to the industry is a plus.
  • Ability to follow strict ICH GCP guidelines, FDA regulations, USDA/AWA requirements, and company SOPs.
  • Ability to acquire knowledge of products and different areas of the business.
  • Excellent organizational and communication skills both written and verbal.
  • Time management skills and problem-solving abilities, including the ability to put a problem into context and suggest pragmatic and practical solutions.
  • Ability to assimilate information rapidly and adapt to different situations/demands.
  • Ability to work independently and with a team.
  • Excellent writing skills, including technical writing skills.
  • Strong coordination skills and compliance with strict timelines are required; experience in leading cross-functional/international matrix teams is preferred;
  • Ability to present self in a highly professional manner in all settings.
  • Computer proficiency, including the use of standard software (word processing, databases, e-mail) and the use of the internetWORKING CONDITIONS:
    • Travel up to 30%, including international travelThe Company is an AA/EEO/Veterans/Disabled Employer.

Keywords: BioIVT, Germantown , Global Auditor-Biotech/Life science, Accounting, Auditing , Winchester, Maryland