On Target Executive Search, A Division Of On Target Staffing LLC

Compensation

Full 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 site’s 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 Bachelor’s 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