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.
Opella values diversity in all its forms and is committed to fostering a workplace where everyone can belong and excel. We welcome and encourage applications from people of all backgrounds.
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