Certified Group

Quality Assurance Coordinator

Certified Group

full-time

Posted on:

Location Type: Office

Location: Melville • New York • United States

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Salary

💰 $25 - $30 per hour

About the role

  • 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.
  • 1-2 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
electronic Quality Management System (eQMS)Corrective and Preventive Action (CAPA)root cause analysisInternal AuditsStandard Operating Procedures (SOPs)cGMP21 CFR Part 11ICH guidelinesinvestigationsquality assurance
Soft Skills
communication skillscollaborationattention to detailanalytical skillsindependencetask prioritizationproject management