Quality Assurance Compliance Specialist, QunolLocation: Pine Brook, NJ
Main Responsibilities: - Manage the end-to-end product complaint process, including complaint intake, evaluation, investigation coordination, supplier corrective actions (ECARs), and timely closure of complaint cases.
- Partner with internal teams, suppliers, and customer service to investigate quality issues, facilitate customer communications, assess supplier responses, and drive effective corrective and preventive actions.
- Lead deviation and out-of-specification (OOS) investigations by initiating documentation, conducting root cause analyses using methodologies such as Fishbone and 5 Whys, and ensuring thorough resolution and closure.
- Collaborate with suppliers and cross-functional stakeholders to ensure timely investigations, regulatory compliance, and continuous improvement of quality systems and processes.
- Administer and deliver quality training programs, assign and track employee training requirements, conduct instructor-led sessions, and serve as a Quality Champion promoting a culture of quality throughout the organization.
- Develop, review, and maintain quality documentation, including SOPs, specifications, and other controlled documents, ensuring alignment with supplier requirements and regulatory standards.
- Support regulatory and external audits while managing change control activities, including initiation, implementation, tracking, and timely completion of all required actions throughout the change lifecycle.
About You:- Bachelor's degree in a technical discipline or equivalent professional experience, with 3+ years of quality compliance experience in a regulated industry.
- Working knowledge of FDA, cGMP/GDP, and other regulatory requirements, with familiarity with Dietary Supplement regulations under CFR 111 preferred.
- Experience conducting and documenting deviations, investigations, root cause analyses, and Out-of-Specification (OOS) reports to support quality system compliance.
- Strong analytical, critical thinking, and problem-solving skills, with the ability to balance quality standards and business objectives while driving continuous improvement initiatives.
- Proven ability to work independently, manage competing priorities with minimal supervision, and deliver results in a fast-paced environment.
- Excellent written and verbal communication skills, with demonstrated success building collaborative relationships across internal teams, suppliers, and external partners.
- Highly organized and detail-oriented team player with proficiency in Microsoft Office and experience using quality management and documentation systems.
This is more than the next step in your career, it's a chance to lead change and help reinvent self-care for the world. If you're ready to challenge, inspire and deliver impact that matters, we're ready for you.
North America Applicants Only
The salary range for this position is: $86,000.00 - $120,000.00
All Compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs.
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