Job Description

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

• Minimum Bachelors degree in a science or technical field such as Pharmacy, Biology, Chemistry, or Engineering .
• 5+ years of experience in pharmaceutical manufacturing or packaging operations under cGMP guidelines.
• Strong understanding of Quality Systems , regulatory requirements , and pharmaceutical production processes (solid dose, topical creams, and ointments).
• Experience in Retail Private Label consumer products is a plus.
• Demonstrated experience interacting with regulatory agencies , third-party auditors , and customers .
• Proven ability to lead teams and ensure consistent, compliant execution of Quality Systems.

Skills

• Self-motivated, proactive, and detail-oriented.
• Exceptional organizational and documentation abilities.
• Strong auditing and analytical skills.
• Ability to collaborate effectively and maintain positive professional relationships.
• Strong multitasking, leadership, and problem-solving abilities.

Benefits

• 401(k)
• Health, Dental, and Vision Insurance
• Life Insurance
• Paid Time Off

Work Location: In person

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