Quality Assurance Auditor I

• Ability to work with all levels of Bioclinica personnel and external personnel in a professional and organized manner.
• Communicating effectively, verbally and in writing, with all internal and external clients
• Performing QA review of source documents, case report forms (CRFs), and other reports for accuracy
• Identifies and implements process improvements, with a focus on the audit program.
• Tracks and/or trends audit issues and/or CAPAs until closure.
• Champions timely management of quality event reports, audit findings, and CAPAs.
• Provides root cause guidance to CAPA owners and/or conducts root cause analysis when assigned.
• Plans, conducts, and reports audits according to Clario's standard operating procedures (SOPs) and electronic document management system (EDMS) processes.
• Escalating quality concerns and problems to the Manager, Quality and Regulatory Compliance or designee(s)
• Supports all audit/inspection types (e.g. internal, external, vendor, regulatory inspections, registrar {ISO, SOC etc.})
• Working directly with Bioclinica development teams to ensure the accuracy and consistency of system development and validation deliverables.
• Follows-up and verifies effectiveness checks
• Support the tracking and trending of all compliance reports and audit activities.

• Supporting and conducting external (vendor/supplier) quality audits and hosts Sponsor/customer audits as needed
• Facilitate quality training of peers on quality related matters as needed

• Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)

• Developing or revising SOPs
• Assisting in establishing and enforcing departmental and regulatory standards

• Exploring new opportunities to add value to organization and departmental processes
• Working with internal staff to resolve issues
• Helping others to achieve results
• Performing other duties as assigned

• Attending and participating in applicable industry or company-sponsored training(s)

• Associate’s degree or equivalent required, preferably in life sciences, clinical trials, quality management, or computer science.
• Quality and/or Quality systems or audit certification, training , or equivalent, is preferred.

• Computer literate and familiar with most common software applications (i.e., Word, Excel etc.)
• Approximately: 1-3 years relevant experience in areas of Quality Assurance, Auditing, Validation, and/or SDLC systems in regulated industries-preferably in Pharmaceutical, CRO, Biotech, Medical device
• Understanding of medical and/or clinical trial terminology is desirable
• Knowledgeable of 21 CFR Part 11, Annex 11, and other applicable ERES regulations
• Possesses a strong working knowledge of Good Clinical Practices (GCP), ICH Guidelines, Software Validation requirements and is competent with quality management systems (QMS)

• Ability to work independently and/or across cross-functional teams; ability to adjust to changing priorities
• Possess high-level ethics and integrity
• Excellent attention to detail and orientation toward meticulous work
• Goal oriented
• Strong interpersonal and communication skills, both verbal and written
• Strong documentation and organizational skills
• Ability to project and maintain a professional and positive attitude
• Proficient at problem-solving
• Ability to manage multiple tasks effectively & efficiently

Collaboration, Continuous Learning, Courageously Curious
Our appetite to blend the best of domain expertise, technology and human understanding knows no bounds. We’re relentless in pursuing the information, insights and inspiration that means we can continuously improve clinical trial site support services and technology solutions.
Behaviors:

• We learn; embracing change, questioning how we work, finding a better way. And if it doesn't go to plan, we don't blame each other; instead, we own it and grow together
• We partner' with each other, with customers, patients and sites, working with them to understand their goals and then deliver the best solutions, Critical Thinking, Deliver Exceptional

We step forward because responsibility powers us; we don’t leave others to do what we can do ourselves. We take charge of events, delivering exceptional work for our customers, patients and each other.
Behaviors:

• We prioritize; focusing on what matters, never compromising on quality.
• We commit; delivering what we say we will, working with energy and intent, sharing what we learn with each other., Organizational Awareness, People first, always

We think of others before we think of ourselves. We have a deep understanding of our customers, and deep empathy for patients—and each other. We’re united by our purpose—it’s why we go above and beyond to support each other, emphatically.
Behaviors:

• We lift each other up; respectful of different views, we listen are inclusive, and support each other to succeed., Results Orientation, Service Orientation
• We do the right thing; for our customers, patients, sites and each other. And We're passionate about it.