Senior Quality Assurance Specialist Job at On Target Executive Search, A Division Of On Target Staffing..., East Brunswick, NJ

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  • On Target Executive Search, A Division Of On Target Staffing...
  • East Brunswick, NJ

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 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

Job Tags

Full time,

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