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.
Job Type: Full-time
Additional pay:
Schedule:
Application question(s):
- How many years of Quality Assurance experience do you have?
- Do you have a strong understanding of Part 11 compliance, including filing requirements related to EDC, as well as regulatory obligations for STATs, CDM, and EDC?
- For this position, we are seeking applicants with experience specifically in CRO, Biotech, or Pharmaceutical industries. Experience in manufacturing is not applicable for this role. Please confirm your relevant experience by responding with 'Yes.'
- Are you able to work hybrid position in Toronto area?
Education:
- Bachelor's Degree (preferred)
Work Location: In person
