QA Compliance Specialist, Qunol

Opella; Pine Brook (NJ); On-site; USD 86,000 - 125,000; Full time

Benefits offered by this job

Employee benefits

Job summary

Opella is seeking a QA Compliance Specialist to lead end-to-end product complaint management and ensure regulatory adherence across the organization. You will coordinate investigations with suppliers and internal teams, drive corrective actions, and champion a culture of quality.

The role demands strong analytical skills, documentation discipline, and the ability to balance regulatory requirements with business goals in a fast-paced environment.

Qualifications

• 3+ years of quality compliance experience in a regulated industry.
• Working knowledge of FDA, cGMP/GDP, and other regulatory requirements; familiarity with Dietary Supplement CFR 111 preferred.
• Experience conducting deviations, investigations, root cause analyses, and OOS reports to support quality system compliance.
• Strong communication, organization, and problem-solving skills; ability to balance quality with business objectives.

Responsibilities

• Manage end-to-end product complaint process from intake to closure.
• Coordinate investigations with internal teams, suppliers, and customer service.
• Lead deviation and OOS investigations with root-cause analyses and timely resolution.
• Collaborate to ensure regulatory compliance and continuous quality improvements.
• Develop and deliver quality training programs and maintain quality documentation.
• Support audits and manage change control activities throughout lifecycle.

Skills

Quality compliance

Regulatory knowledge

Analytical skills

Communication

Project management

Microsoft Office

Education

Bachelor’s degree or equivalent experience

Tools

Microsoft Office

Job description

Salary Range

$86,250.00 - $124,583.33

All Compensation Will Be Determined Commensurate With Demonstrated Experience.

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

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.

About the Job

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.

Qualifications

• 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.

Benefits

• Employees may be eligible to participate in Company employee benefit programs.

Additional Information

• 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.

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.

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