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.

Job Functions

• 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 controlInvestigating 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 deviationsTraining of new departmental staff
• Other duties or tasks assigned by manager or supervisor
• Encourage prompt reporting of health and safety concerns.

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 with Jurisdictional / ISO requirements

Additional Information: Compensation

The expected salary for this position is $28.00 to $35.00 per hour. This range represents the minimum and maximum base salary we reasonably expect to pay for this role. Actual compensation within the range will depend on skills, experience, and qualifications.

Our Benefits

We care about your total well-being and will support you with the following, subject to your location and role.

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

• In compliance with applicable state and local pay transparency laws, we provide clear and equitable compensation information for all applicants.
• Position anticipated to close August 31, 2026.
• Additional information

This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time.

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