QA Compliance Lead: Investigations & Training

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

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.