QA Associate - Robarts Clinical Trials Company Location London, CA
Nada Aboshawish 3536
Joined 09/23/2018 - 15 Posts

Seniority Level

Entry level

Industry

  • Research
  •  
  • Biotechnology
  •  
  • Hospital & Health Care

Employment Type

Full-time

Job Functions

  • Quality Assurance

DEPARTMENT/UNIT NAME: Quality Assurance

Job Summary

Responsible to support the development, implementation, maintenance and monitoring of Quality Management Systems (QMS) and activities in the execution of Quality Assurance Deliverables. Responsible for supporting the business in Quality Assurance, through audit activities in support of ongoing quality improvement. Acts as a liaison with other business units and partners and assumes some responsibilities for Quality led-initiatives, based upon knowledge of regulations, standards and industry best practices.

Areas Of Responsibility

Quality Assurance Implementation
  • Assist in the implementation of the corporate Quality Plan.
  • Identify indicators need to assess quality levels.
  • Evaluate quality activities against corporate standards and regulatory requirements.
  • Assist in audits (internal, site, vendor) and review peer reports.
  • Facilitate the development/revision of QMS policies, SOPs, Work Instructions, standards and training materials as required.
  • Assist in the provision of guidance to departments in the interpretation of regulatory requirements.
Regulatory, Ethical Conduct, and Audit Monitoring
  • Remain current on and ensure internal awareness of relevant regulatory requirements, industry standards and requirements.
  • Assist in the identification of QMS documents and/or training requirements to meet regulations, standards and sponsor expectations.
  • Facilitate Sponsor and regulatory inspections or audit activities.
QA Training
  • Identify, create, adapt and deliver quality assurance orientation as well as department, project team and clinical site quality assurance training programs and tools.
  • Monitor training compliance of the organization.
Qualifications

Applicants should have a minimum of an undergraduate degree and 1-3 years of relevant experience (ideally Clinical Research, Life Sciences, Professional Services, Quality Assurance, or Software Development) OR a college diploma and 3-5 years of relevant experience + substantial on-the-job training. Knowledge of Good Clinical Practice (GCP) is an asset.

Working Conditions

Office-based
  • Accommodations for job applicants with disabilities