Quality and Regulatory Specialist - Flamability Lab

About the Position

Quality and Regulatory Specialist - Flamability Lab

Farmingdale, NY, United States

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, we provide 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. And we will be 100% committed to helping you reach your full potential.

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.

Requirements

• Education: High School Diploma or equivalent (Required), Engineering Technology Diploma (Preferred)
• Experience: 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

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

• 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

About the Company

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 company’s 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 201-508-3149 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.