Posted

30+ days ago

Location

Newark, CA

Description

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.


About the Company

BioClinica Inc

The Leader in Clinical Trial Management Solutions

Bioclinica is divided into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging and Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Biomarker Laboratory. Our eHealth segment comprises an eClinical Solutions Division along with Safety and Regulatory Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

Company Size

2,000 to 2,499 employees

Industry

Biotechnology/Pharmaceuticals

Founded

1990

Website

http://www.bioclinica.com/