Quality Assurance Specialist

Certified Group is a leading North American provider of laboratory testing and audit and certification services. The Certified Group of companies includes Food Safety Net Services (FSNS), Certified Laboratories, EAS Consulting Group, Labstat International Inc. The Certified Group provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, cannabis, nicotine, 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.

ESSENTIAL FUNCTIONS:

• 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:

• Bachelor's degree in a scientific or technical field, such as Chemistry, Biology, Engineering, or related discipline.
• 5-10 years of experience in a quality assurance role within an FDA regulated industry, preferably in pharmaceuticals, medical devices, or biotechnology.
• Strong understanding of FDA regulations and guidelines, including cGMP, 21 CFR Part 11, and ICH guidelines.
• Proven experience in managing electronic Quality Management Systems (eQMS), such as Qualtrax, Intact, or similar platforms.
• Proficiency in conducting investigations, root cause analysis, and implementing corrective actions for CAPA, Customer Complaints, and OOS events.
• Experience in conducting Internal Audits and familiarity with audit processes and methodologies.
• Excellent communication skills, with the ability to effectively collaborate with cross-functional teams and communicate quality requirements to stakeholders at all levels of the organization.
• Strong attention to detail and analytical skills, with the ability to analyze complex data sets and identify trends or areas for improvement.
• Ability to work independently, prioritize tasks, and manage multiple projects simultaneously in a fast-paced environment.

BENEFITS:

• Progressive 401k Retirement Savings Plan
• Employer Paid Short- Term and Long-Term Disability, and Life Insurance
• Group Medical
• Tuition Reimbursement
• Flexible Spending Accounts
• Dental
• Paid Holidays and Time Off
• Many positions which qualify for the company bonus program

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.