QA Compliance Specialist, Qunol

Opella•Montville Township, NJ

4d•$86,000 - $120,000•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

familiarity with Dietary Supplement regulations under CFR 111

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.