QA Compliance Specialist — Regulatory Quality & Training Lead

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

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.