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.

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 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

SGS is an Equal Opportunity Employer and as such we recruit hire train and promote persons in all job classifications without regard to race color religion sex national origin disability age marital status sexual orientation gender identity or expression genetics status as a protected veteran or any other characteristics protected by law.

To perform this job successfully an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge skills and/or abilities required.

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 companys rights to assign or reassign duties and responsibilities to this job at any time.

If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability please call for assistance and leave a message. You will receive a callback.  Please note this phone number is not for general employment information but is only for individuals who are experiencing difficulty applying for a position due to a disability.

Remote Work :

No

Employment Type :

Full-time