Senior Quality Assurance Specialist (East Brunswick)
On Target Executive Search, A Division Of On Target Staffing LLCEast Brunswick, NJ, USjob_description.job_card.variable_hours_ago
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job_description.job_card.job_descriptionMinimum 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. 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. 401(k) Health, Dental, and Vision Insurance Life Insurance Paid Time Off
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
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Quality Assurance Specialist • East Brunswick, NJ, US