Senior Quality Assurance Specialist (East Brunswick)

Senior Quality Assurance Specialist

Location : East Brunswick, NJ ONSITE

Job Type : Full-time

Our pharmaceutical manufacturing client is a leading supplier and packager of over-the-counter medications and dietary supplements. We are seeking a hands-on Quality Assurance professional with senior-level cGMP and Quality Systems experience to join the team. The ideal candidate is a proactive leader who thrives in a collaborative, fast-paced environment and has experience working directly with regulatory authorities.

Key Responsibilities

• Lead Site Compliance meetings and support compliance programs.
• Ensure consistent execution of Quality Systems across all manufacturing operations.
• Drive efficiency and effectiveness of compliance programs and quality systems.
• Oversee Deviation Management and CAPA (Corrective and Preventive Actions) processes.
• Manage Product Quality Complaints , Change Controls , and Quality Risk Management .
• Oversee cGMP documentation and ensure adherence to quality standards.
• Support Regulatory Program Management (Field Alerts, APRs, Inspections, Compliance Improvement Plans, Site Master Plans, etc.).
• Prepare and assist with Annual Product Reviews .
• Manage the sites Quality Assurance Document Control and Records Management systems.
• Stay informed of evolving regulatory and industry trends to ensure proactive compliance.
• Conduct and oversee OQ, IQ, PQ , and cleaning validations .
• Support customer-related documentation requests and audits.
• Perform additional Quality Assurance duties as assigned.

Experience & Qualifications

Skills

Benefits

Work Location : In person