Regulatory and Quality Specialist - Labware - Millville, NJ

About the role

The Quality & Regulatory Specialist supports quality assurance and regulatory compliance activities for laboratory glassware, packaging, and life sciences products. This role is responsible for maintaining quality systems, supporting audits and certifications, managing documentation, ensuring compliance with applicable regulatory requirements, and driving continuous improvement initiatives.

Responsibilities

• Support the maintenance and continuous improvement of the Quality Management System (QMS).
• Ensure compliance with applicable quality, regulatory, and industry standards, including ISO requirements and Good Manufacturing Practices (GMP), as applicable.
• Review, create, and maintain quality and regulatory documentation, including procedures, work instructions, specifications, and records.
• Capture, organize, and maintain quality and regulatory documentation.
• Coordinate document control activities and ensure accurate record retention.
• Absorb, prepare, execute, and follow up on corrective actions during internal, customer, and third-party audits.
• Investigate quality issues, nonconformances, complaints, and deviations; support root cause analysis and corrective/preventive action (CAPA) implementation.
• Maintain quality metrics and prepare reports to support management review and continuous improvement efforts.
• Review change controls and assess potential quality and regulatory impacts.
• Support supplier qualification activities and participate in supplier quality evaluations.
• Absorb, prepare, execute, and follow up on product certifications, declarations of conformity, and customer regulatory inquiries.
• Collaborate with Manufacturing, Engineering, Operations, and Customer Service teams to resolve quality and compliance-related issues.
• Participate in risk assessments and validation activities as required.
• Stay current with evolving regulatory requirements and industry best practices.

Requirements

• Bachelor's degree in Quality Assurance, Chemistry, Biology, Engineering, Regulatory Affairs, or a related scientific discipline. Relevant work experience will also be considered.
• 1-5 years of experience in quality assurance, regulatory affairs, manufacturing quality, or a related role.
• Knowledge of Quality Management Systems and relevant ISO standards.
• Experience with CAPA, root cause analysis, audits, and document control processes.
• Strong understanding of regulatory compliance requirements within manufacturing, laboratory, medical device, pharmaceutical, or life sciences environments.

Qualifications

• Ability to work independently and as part of a team.
• Strong communication and interpersonal skills.
• Proficiency in Microsoft Office Suite.
• Ability to manage multiple tasks and priorities.
• Ability to learn and adapt to new technologies and processes.

Skills

• Quality Management Systems (QMS)
• Good Manufacturing Practices (GMP)
• ISO Standards
• Document Control
• Internal and External Audits
• Root Cause Analysis
• Corrective and Preventative Actions (CAPA)
• Supplier Qualification
• Product Certifications
• Regulatory Compliance
• Quality Metrics
• Risk Assessments
• Validation Activities
• Evolving Regulatory Requirements
• Industry Best Practices

Benefits

Competitive Base Salary
Excellent Benefits
401(k) Company Matching Program
Growth potential within the organization