Quality Specialist

Job Description

Job Description

Certified Group partners with customers to deliver innovative scientific solutions and expertise – So The World Can Trust In What It Consumes™. As a leading provider of laboratory testing, regulatory consulting, and certification & audit services, Certified Group includes Food Safety Net Services (FSNS), FSNS Certification & Audit, Certified Laboratories, EAS Consulting Group, and Labstat International Inc. Certified Group provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, nicotine, cannabis, and hemp industries.

We are seeking a highly skilled Quality Assurance Specialist to join our team!

In this key role you will work on ensuring compliance with FDA regulations within our industry. The ideal candidate will have extensive experience in managing electronic Quality Management Systems (eQMS), particularly in areas such as Corrective and Preventive Actions (CAPA), Customer Complaints, Out of Specification (OOS) investigations, and conducting Internal Audits. The Quality Assurance Specialist will play a pivotal role in maintaining and improving our quality management processes to uphold the highest standards of product quality and regulatory compliance.

Responsibilities :

• Assist in the implementation, maintenance, and continuous improvement of the electronic Quality Management System (eQMS) to ensure compliance with FDA regulations.
• Lead and coordinate Corrective and Preventive Action (CAPA) processes, including investigation, root cause analysis, implementation of corrective actions, and effectiveness checks.
• Handle Customer Complaints and Out of Specification (OOS) investigations, ensuring timely resolution and documentation according to regulatory requirements.
• Conduct thorough Internal Audits to assess compliance with established quality procedures, identify areas for improvement, and develop corrective actions as needed.
• Collaborate with cross-functional teams to provide quality assurance guidance and support throughout all stages of operation.
• Develop and maintain quality-related documentation, including Standard Operating Procedures (SOPs), work instructions, and quality records, in accordance with FDA regulations.
• Assist in the preparation and hosting of regulatory agency inspections and audits, as well as follow-up activities to address any findings or observations.
• Stay abreast of regulatory requirements and industry best practices related to quality assurance and quality management systems, and proactively implement necessary changes to ensure compliance.

Requirements :

BENEFITS :

Certified Group values diversity in its workforce. The company is firmly committed to a policy of Equal Opportunity and will administer its policies in a manner that treats each employee and applicant for employment on the basis of merit. Certified Group will take affirmative action to seek out qualified applicants without regard to race, color, religion, sex, national origin, age, handicap, or veteran status.