Quality Assurance Specialist

2 months ago

Markham, Ontario, Canada Everest Clinical Research Services Inc Full time

Everest Clinical Research Services Inc is a leading contract research organization (CRO) providing a wide range of expertise-based clinical research services to the pharmaceutical, biotechnology, and medical device industries.

We are a dynamic organization with a strong foundation in statistical and data management, and we have successfully developed and established ourselves as a full-service CRO.

Our team is known for delivering high-quality results, providing exceptional customer service, and being flexible in meeting clients' needs.

To drive continued success, we are seeking a highly skilled and experienced individual to join our team as a Senior Quality Assurance Auditor.

Responsibilities:

• Conduct scheduled internal audits to assess compliance with applicable regulatory requirements and company Standard Operating Procedures (SOPs).

• Document and report audit findings in a timely manner.

• Lead corrective and preventative actions investigations and follow-up on compliance issues until resolution.

• Maintain the company's governing documents according to SOPs, including entering tracking information into a database and updating records when documents are updated.

• Assist with external audits by clients and regulatory inspections.

• Conduct vendor qualification assessments and coordinate the assessment effort as needed.

• Conduct employee training on QA procedures.

• Follow-up with project managers to ensure that study-specific training and project kick-off meetings are properly conducted.

• Stay up-to-date with industry best practices in quality control and quality assurance by researching and participating in relevant training and association activities.

Requirements:

• Bachelor's degree in a relevant field, such as health science, physics, biology, or mathematics.

• Certification as a quality auditor (ASQ, ISO, or equivalent).

• At least 6 years of experience in a clinical research capacity.

• At least 6 years of auditing experience.

• At least 1 year of experience with regulatory inspections.

• Knowledge of clinical trial processes and procedures.

• Knowledge of pharmaceutical industry regulatory requirements.

• Comprehensive knowledge of ICH and GCP guidelines.

• Strong analytical and problem-solving skills.

• Excellent communication and interpersonal skills.

• Ability to work independently and as part of a team.

• Strong attention to detail and organizational skills.

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