Auditor I, Medical Imaging

Primary Responsibilities

Supports all aspects of audits / audit conduct

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

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

Secondary Responsibilities

Maintains Quality Service and Departmental Standards by

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

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

Contributes to team effort by

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

Maintains Technical and Industry Knowledge by

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

Qualifications:

Education:

• Associate’s degree or equivalent required, preferably in life sciences, trial or quality management, or computer science
• Quality and/or computer systems certification (e.g. ASQ Auditor), or equivalent, is preferred

Experience:

• Approximately: 0-3 years relevant experience in areas of Quality Assurance, Auditing, Validation, and/or SDLC systems in regulated industries-preferably in Pharmaceutical, CRO, Biotech, Medical device
• Possesses a strong working knowledge of Good Clinical Practices (GCP), ICH Guidelines, Software Validation requirements and is competent with quality management systems (QMS)
• Knowledgeable of 21 CFR Part 11, Annex 11, and other applicable ERES regulations
• Computer literate and familiar with most common software applications (i.e., Word, Excel etc.)
• Understanding of medical and/or clinical trial terminology is desirable

Additional skill set:

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

The above qualifications will either be satisfied upon hire or through mentorship and oversight by a qualified Quality Assurance team member.

Working conditions:

Travel:  0-10%

Lifting:  0-25 lbs

Other:  Computer work for long periods of time

This JOB description should not be deemed all-inclusive.  Additional requirements and expectations may be assigned.  At all times, employees are expected to adhere to company policies and company SOPs.