QA Compliance Specialist, Qunol

Opella • Montville Township, NJ

11d • $86,250 - $124,583

About The Position

The QA Compliance Specialist at Qunol/Opella manages product complaint handling, quality investigations, training, documentation, audits, and change control. The role works with internal teams, suppliers, customer service, and external partners to address quality concerns, maintain regulatory compliance, and improve quality systems and processes. It also contributes to a collaborative, inclusive culture and supports Opella’s mission to make self-care simpler, with sustainability, access, and social impact considered in decision-making.

Requirements

• Bachelor’s degree in a technical discipline or equivalent professional experience.
• At least 3 years of quality compliance experience in a regulated industry.
• Working knowledge of FDA, cGMP/GDP, and other regulatory requirements.
• Experience conducting and documenting deviations, investigations, root cause analyses, and OOS reports.
• Strong analytical, critical-thinking, and problem-solving skills, including the ability to balance quality standards with business objectives and drive continuous improvement.
• Ability to work independently, manage competing priorities with minimal supervision, and deliver results in a fast-paced environment.
• Excellent written and verbal communication skills and ability to build collaborative relationships across internal teams, suppliers, and external partners.
• Highly organized and detail-oriented team player.
• Proficiency in Microsoft Office and experience using quality management and documentation systems.

Nice To Haves

• Familiarity with Dietary Supplement regulations under CFR 111.

Responsibilities

• Manage product complaints end to end, including intake, evaluation, investigation coordination, supplier corrective actions (ECARs), and timely case closure.
• Work with internal teams, suppliers, and customer service to investigate quality issues, support customer communications, assess supplier responses, and drive corrective and preventive actions.
• Lead deviation and out-of-specification (OOS) investigations, initiate documentation, conduct root cause analyses using methods such as Fishbone and 5 Whys, and ensure resolution and closure.
• Coordinate with suppliers and cross-functional stakeholders to support timely investigations, regulatory compliance, and continuous improvement of quality systems and processes.
• Administer and deliver quality training programs, assign and track employee training, conduct instructor-led sessions, and promote a culture of quality as a Quality Champion.
• Develop, review, and maintain SOPs, specifications, and other controlled quality documents in alignment with supplier requirements and regulatory standards.
• Support regulatory and external audits.
• Manage change control from initiation through implementation, tracking, and completion of required actions.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level