QA Compliance Specialist, Qunol

1358 Quten Research Institute LLC; Pine Brook (NJ); On-site; USD 86,000 - 125,000; Full time

Job summary

Opella is seeking a Quality Assurance Compliance Specialist in Pine Brook, NJ to manage end-to-end product complaints and lead investigations, deviations, and CAPAs. The role requires 3+ years in quality compliance within regulated industries and familiarity with FDA/cGMP requirements.

The candidate will train staff, maintain quality documentation, and support audits while collaborating with internal teams and suppliers to drive continuous improvement and ensure regulatory alignment.

Qualifications

• Bachelor’s degree in a technical discipline or equivalent professional experience.
• Working knowledge of FDA, cGMP/GDP, and other regulatory requirements, with familiarity with Dietary Supplement regulations under CFR 111 preferred.
• Experience conducting 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.
• 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.

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.

Skills

Quality compliance

Regulatory knowledge

Analytical thinking

Problem solving

Excellent communication

Education

Bachelor's degree in technical discipline

Tools

Microsoft Office

Quality management systems

Job description

Quality Assurance Compliance Specialist, Qunol Location: Pine Brook, NJ

Salary Range: $86,250.00 - $124,583.33 All Compensation will be determined commensurate with demonstrated experience.

About the Job

You’ve built experience, now use it where bold ideas meet real impact. At Opella, we’re challenging how self-care works for millions of people and need leaders and experts ready to shape what’s next. As a QA Compliance Specialist, you’ll bring your skill, your curiosity and your drive to make health simpler, smarter and more human.

Lead initiatives that advance our brands and strengthen our reputation worldwide. Mentor and uplift emerging talent while pushing your own growth and influence. Put purpose into practice — embedding sustainability, access and social impact into every decision. Model the challenger mindset: question complexity, act with integrity and make things radically simple. Help shape a culture that’s ambitious, collaborative and serious about recognition and belonging.

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. We are challengers. We are Opella. 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.

About Us

Opella is the self-care challenger with the purest and third-largest portfolio in the Over The Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.