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About the Role
Quality and Regulatory Specialist is responsible for ensuring compliance with quality standards, federal regulations, industry guidelines, and company procedures. This role requires maintaining 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.
- Reviews company policies and procedures to ensure they meet regulatory standards.
- Collaborates with operational teams to ensure regulatory compliance is considered during the design process and scope of delivery.
- Prepares and submits documentation to regulatory agencies and accrediting bodies, as needed.
- Keeps up-to-date with changes in regulatory legislation, guidelines, and industry standards.
- Monitors and sets standards for quality control.
- Investigates and sets standards for safety and health.
- Assesses outcome, compliance, or operational risks and develops risk management strategies.
- Conducts internal audits to measure and assure adherence to established QA standards in accordance with applicable regulations and guidelines.
- Trains staff and team members about quality, regulatory, and compliance issues.
- Maintains and organizes necessary documentation.
- Addresses 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.
- Assists with documentation of root-cause analysis stemming from internal non-conformances, corrective actions, and preventive actions.
- Assists in the review of clinical study protocol deviations.
- Trains new departmental staff.
- Performs other duties or tasks assigned by manager or supervisor.
- Encourages prompt reporting of health and safety concerns.
Requirements
- High School Diploma or equivalent (Required)
- Minimum 5 years relevant experience (Required)
- Supervisory experience is an asset (Preferred)
Skills
- Ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
- Good organizational/time management skills.
- Familiarity with Jurisdictional / ISO requirements.
Location
- United States
Work Type
- Full-time
Experience Level
- Minimum 5 years relevant experience
Education Level
- High School Diploma or equivalent
- Engineering Technology Diploma (Preferred)
Salary/Compensations
- USD 28.00 - USD 35.00 - hourly
Benefits
- Medical, dental and vision insurance
- Life insurance
- Employee assistance programs
- 401(k) with company match (immediate vesting upon enrollment)
- Online training courses
- Virtual and classroom development experiences
- Tuition reimbursement program
- Paid-time off
- Family leave
About the Company
- SGS is the global leader and innovator in inspection, verification, testing and certification services.
- Founded in 1878, SGS is recognized as the global benchmark in quality and integrity.
- With over 97,000 employees in 130 countries and operating a network of more than 2,400 offices and laboratories, SGS provides services to almost every industry by assuring quality and safety of products and services.
- Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do.
- We encourage new ideas.
- We welcome people who challenge the way we do things.
- We will be 100% committed to helping you reach your full potential.
Equal Opportunity
- 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.