Quality Assurance Specialist

22 hours, 16 minutes ago
Full-time
Senior
Quality Assurance and Testing
Alimentiv

Alimentiv

Alimentiv specializes in providing comprehensive clinical research services for gastrointestinal and liver diseases, leveraging a global site network, advanced medical imaging, and biomarker discovery to enhance patient recruitment and accelerate clini...

Professional Services
251-1K
Founded 1986

Description

  • Provide senior support for the planning, organization, and evaluation of day-to-day global quality assurance services.
  • Support quality assurance, policy planning and development, and ongoing quality improvement through clinical audit activities.
  • Liaise with other business units and external partners to support QA initiatives and resolve issues.
  • Implement quality assurance plans and processes and define indicators used to assess product and service quality.
  • Collaborate with management, functional experts, and sponsors to identify requirements for internal audits, site audits, vendor assessments, and vendor audits.
  • Oversee the development of Quality System documents, including policies, procedures, instructions, guidance, forms, and templates.
  • Develop QA processes and train, support, and oversee junior QA staff.
  • Monitor regulatory trial conduct standards and identify changes to regulations governing clinical research.
  • Plan, lead, and facilitate sponsor and regulatory inspections and audit activities, including staff preparation and follow-up on findings.
  • Communicate audit findings, support root cause analysis and corrective and preventive actions, and assist departments with sponsor requests and privacy-related inquiries.

Requirements

  • Undergraduate degree with 4-6 years of related experience and on-the-job training, or a college diploma with 7-9 years of related experience and training.
  • Preferred background in Life Sciences, Clinical Research, Information Technology, or Clinical Quality Assurance.
  • Strong analytical, critical thinking, and problem-solving skills.
  • Knowledge of ICH GCP and global regulations governing clinical research.
  • Knowledge of global privacy regulations.
  • Experience supporting internal audits, site audits, vendor assessments, or vendor audits is expected.
  • Ability to interpret, communicate, and implement regulatory and ethical conduct requirements.
  • Experience developing policies, processes, training, or Quality System documentation is an asset.
  • Experience working with cross-functional teams and senior stakeholders is preferred.
  • Familiarity with clinical research compliance and quality assurance practices is preferred.

Benefits

  • Salary range of $78,000 to $130,000 per year.
  • Remote work arrangement.
  • Full-time, permanent position.
  • Opportunities to support anticipated QA Specialist vacancies in Canada over the coming year.
  • Recruitment process uses human review and final hiring decisions are made by people.

Interested in this position?

Apply directly on the company website

Apply Now

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