Quality and Regulatory Specialist - Flamability Lab

SGS•Farmingdale, NY

77d•$28 - $35

About The Position

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.

Requirements

High School Diploma or equivalent (Required)
Minimum 5 years relevant experience (Required)
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

Nice To Haves

Engineering Technology Diploma (Preferred)
Supervisory experience is an asset (Preferred)

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.