Quality Assurance Specialist

2 weeks ago

Toronto, Canada Candido Consulting Group Inc Full time

Our client, based in Toronto, is seeking an experienced and detail-oriented Quality Assurance Specialist to join their growing team.


The successful candidate will be reporting to the Director, QA, and will be the on-site QA resource for administering the company's quality program.

This role will work with Operations and Management to ensure the effectiveness and compliance of the quality system. 


Key Responsibilities
  • Coordinate annual training activities (SOP Training, GCP training), maintain the training library and deliver QS training to staff.
  • Participate in the development and management of SOPs, policies and other QS documents and coordinate the review and development of these documents. Review and revise departmental procedures as needed.
  • Maintain quality system records in an organized and easily retrievable manner. Records include those generated through audit, SOP management, training, deviation & CAPA processes, the software system release list and catalogue of validation documents.
  • Assist with supplier qualification and reassessment activities.
  • Participate in hosting external audits.
  • Conduct internal audits to assure ongoing compliance with applicable SOPs, regulations and GCP. 
  • Track deviation, CAPA, Change Control progress and coordinate activities and investigations with Operations.
  • Act as a QA resource for validation of proprietary systems, author or review validation documentation.
  • Participate in projects and assignments that support continued improvement of the quality system.
  • Other duties as assigned.


Qualifications
  • Bachelor’s degree in relevant scientific field or Information Technology
  • 3 - 5 years of experience, preferred 5+
  • Demonstrated knowledge and understanding of quality systems (e.g. ISO 9001:2015), document control, and document management.
  • Demonstrated knowledge and understanding of drug development processes and applicable GCP/ICH/FDA regulations and guidelines, including those for development of computerized systems for clinical research.
  • Experience in conducting and hosting audits and managing follow up to audit close
  • Independent worker and self-starter with effective organizational, presentation, documentation and interpersonal skills.
  • Demonstrated effectiveness in prioritizing work assignments and to deliver completed work within the guidelines of departmental policies and procedures.
  • Proficient written and oral communication skills.
  • Competent using Microsoft Word, Excel and other common office software.


Nice to have:

  • Knowledge of computer systems development and validation methodology, and clinical data management and biostatistics processes.
  • Knowledge of databases (e.g. Lotus Notes), and SAS.


This is a full time, permanent, on-site position. Candidates must be eligible to work in Canada.

We thank all applicants for their interest, however only those candidates selected for interviews will be contacted.

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