Global Auditor-Biotech/Life science
Posted on: November 22, 2021
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
- Coordinate auditing activities.
- Potential to build an auditing/monitoring team; Manage
- Perform routine audits remotely and/or in person.
- Develop audit/monitoring specific SOPs, work instructions,
- Create reports and maintain tracking.
- Advise the business on corrective and preventative action
- 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
- 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 &
- 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
- 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
- Excellent organizational and communication skills both written
- Time management skills and problem-solving abilities, including
the ability to put a problem into context and suggest pragmatic and
- Ability to assimilate information rapidly and adapt to
- Ability to work independently and with a team.
- Excellent writing skills, including technical writing
- 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
- Computer proficiency, including the use of standard software
(word processing, databases, e-mail) and the use of the
- 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
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