Quality Manager: FDA GMP & OTC Compliance

Quest Products, LLC; Phoenix (AZ); On-site; USD 90,000 - 130,000; Full time

Job summary

Quest Products LLC, a manufacturer of OTC drug products, seeks a Quality Manager to sustain and improve the QMS for cGMP-compliant production, testing, packaging, and release of OTC products, including enema products.

You will own batch review, deviations, CAPA, audits, and FDA inspection readiness, while collaborating with Operations, Regulatory Affairs, and Supply Chain to drive continuous improvement.

Qualifications

• Bachelor's degree in a scientific, engineering, or related technical discipline.
• 3–5 years in QA/QC in FDA-regulated manufacturing (OTC/Pharma/Med device).
• Experience with batch review, deviation, CAPA, and change control processes.
• Participation in FDA inspections or third-party audits preferred.
• Strong written and verbal communication; proficient QMS software skills.

Responsibilities

• Review batch production records and test results prior to release.
• Maintain and improve the site's Quality Management System (QMS).
• Lead deviation, OOS/OOT, CAPA, and change control activities.
• Manage product complaint handling and audit responses.
• Coordinate internal audits and support FDA/customer inspections.
• Oversee supplier qualification and material inspection programs.
• Oversee IQ/OQ/PQ validation and cleaning validation activities.
• Maintain document control, training records, and SOP lifecycle.
• Provide quality-related training to staff and monitor quality metrics.
• Collaborate with Operations, Regulatory, R&D, and Supply Chain.

Skills

cGMP knowledge

Batch record review

FDA inspections

Supplier quality management

Quality systems

Education

Bachelor's degree in science or engineering

Tools

MasterControl

TrackWise

Veeva QMS

ETQ

Job description

Quest Products LLC, a manufacturer of OTC drug products, seeks a Quality Manager to sustain and improve the QMS for cGMP-compliant production, testing, packaging, and release of OTC products, including enema products.

You will own batch review, deviations, CAPA, audits, and FDA inspection readiness, while collaborating with Operations, Regulatory Affairs, and Supply Chain to drive continuous improvement.