Quality and Regulatory Specialist - Flamability Lab

Position Summary

Quality and Regulatory Specialist is responsible for ensuring compliance with quality standards, federal regulations, industry guidelines and company procedures. Maintain knowledge of Good Clinical Practices (GCP), Good Laboratory Practices (GLP), ISO 17025:2017, Standard Operating Procedures (SOP), and Federal and applicable regulations.

Responsibilities

• Performs review of protocols, informed consents, and case reports forms (CRFs) prior to study initiation and revised documents
• Review company policies and procedures to ensure they meet regulatory standards
• Collaborate with operational teams to ensure regulatory compliance is considered during the design process and scope of delivery
• Preparing and submitting documentation to regulatory agencies and accrediting bodies, as needed
• Keeping up-to-date with changes in regulatory legislation, guidelines, and industry standards
• Monitoring and setting standards for quality control
• Investigating and setting standards for safety and health
• Assessing outcome, compliance, or operational risks and developing risk management strategies
• Conducting internal audits to measure and assure adherence to established QA standards in accordance with applicable regulations and guidelines
• Training staff and team members about quality, regulatory, and compliance issues
• Maintaining and organizing necessary documentation
• Addressing non-compliance issues
• Works directly with international coordinators and project managers to ensure accurate documentation is performed for clients
• Conducts audits of clinical trial master files, source data, and procedures for protocol, monitoring plan (when applicable) SOP, and GCP/ICH compliance
• Assists with auditing the company training files
• Assist with documentation of root-cause analysis stemming from internal non-conformances, corrective actions, and preventive actions
• Assist in the review of clinical study protocol deviations
• Training of new departmental staff
• Other duties or tasks assigned by manager or supervisor
• Encourage prompt reporting of health and safety concerns

Qualifications

Education and Experience

• High School Diploma or equivalent (Required)
• Engineering Technology Diploma (Preferred)
• Minimum 5 years relevant experience (Required)
• Supervisory experience is an asset (Preferred)

Knowledge / Skills / Abilities

• Ability to manage and coordinate multiple projects in a fast-paced, highly professional environment
• Good organizational/time management skills
• Familiarity with Jurisdictional / ISO requirements

Pay

$28.00 to $35.00 per hour. Actual compensation within the range will depend on skills, experience, and qualifications.

Benefits

• Health: Medical, dental and vision insurance, life insurance, employee assistance programs
• Wealth: 401(k) with company match (immediate vesting upon enrollment)
• Professional Growth: Online training courses, virtual and classroom development experiences, tuition reimbursement program
• Work-Life Balance: Paid-time off and family leave