Quality Assurance/Regulatory Specialist II @ Nelson Labs - Fairfield, NJ 07004

Job Overview

a month ago

Quality Assurance/Regulatory Specialist II

Nelson Labs - Fairfield, NJ 07004

At Nelson Laboratories, a Sotera Health Company, our employees are part of an industry-leading, global provider of laboratory testing and consulting services; dedicated to the mission of helping the best companies in the world improve the quality of life by providing the highest standard in laboratory testing.

Our employees receive competitive pay, growth and learning opportunities, insurance benefits, tuition reimbursement, paid holidays and PTO, and the opportunity to attend many company-sponsored employee and family events. Safeguarding Global Health. It's what we do!

Summary

Regulatory Affairs oversees the quality system and uses a risk based approach to ensure regulatory compliance for Nelson Labs.

The Regulatory Specialist II is responsible for quality system and investigation processes, which may include agreements, change management, failure investigations, quality events, supply/supplier management, complaints and/or CAPA. The Regulatory Specialist II also supports the audit-ready philosophy of the company through participation in the internal and external audit processes and provides support to company functions as needed.

Essential Job Duties

  • Regulatory Compliance - follow applicable regulatory requirements (GMP, GLP, ISO, etc.)
  • Agreements - review, negotiate, approve and track quality, lab, service and change agreements
  • Failure Investigations - perform Product Sterility failure and sample positive investigations to determine if positives are attributed to the laboratory
  • Quality Events complete QE documentation, perform risk assessment to determine if full investigation and/or corrective/preventative action is necessary
  • CAPA - Coordinate with area managers to perform root cause analysis and develop action plan
  • Complaints Coordinate with area managers to investigate and respond to complaints
  • Supplier Management - approve new suppliers and perform annual assessments of suppliers
  • Internal Audits perform inspection and quality management system audits
  • External Audits host client quality audits, provide a facility tour, obtain requested documents for the auditor to review, respond to auditor questions, and respond to findings identified in the audit report.

Educational Requirements

  • A.S with three years quality experience OR B.S with two years quality experience
  • CQA or equivalent certification preferred

Desired Skills

  • Demonstrated knowledge of GMP, GLP, and ISO 17025 regulatory requirements
  • Strong experience and understanding of CAPA
  • Support of customers, members of staff and management
  • Prioritization of tasks from a risk based approach, critical time management and deadline focus
  • Demonstrated knowledge of trend analysis
  • Experience hosting, processing, documenting and reviewing audits

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