Job Description

Job Description

Job Description

JOB PURPOSE

The Quality Assurance Manager is responsible for leading and maintaining the Quality Management System (QMS) to

ensure cosmetic and OTC products are manufactured in compliance with FDA regulations, cGMPs, and applicable ISO

standards. This role provides quality oversight for manufacturing operations, supports regulatory inspections, and drives

continuous improvement across the organization.

DUTIES & RESPONSIBILITIES

· Develop, implement, and maintain the QMS in accordance with FDA, cGMP, and ISO requirements.

· Oversee deviations, CAPAs, change controls, and root cause investigations.

· Ensure effective document control and approval of quality-related records.

· Establish and monitor quality metrics to assess compliance and performance.

· Lead and support FDA inspections, customer audits, and third-party audits.

· Prepare audit responses and ensure timely closure of observations.

· Maintain inspection readiness and support regulatory submissions as needed.

· Provide QA oversight of manufacturing, packaging, labeling, and warehouse operations.

· Partner with Operations and related functions to ensure GMP compliance and product quality.

· Support validation, supplier quality, and material qualification activities.

· Lead, mentor, and develop the QA team.

· Ensure GMP and quality training programs are implemented and maintained.

· Promote a culture of quality, accountability, and continuous improvement.

· Serve as a primary quality contact for customers.

· Manage customer complaints and drive effective investigations and corrective actions.

QUALIFICATIONS

· Bachelor’s degree in a scientific or related field required.

· 5+ years of QA experience in cosmetics, OTC, pharmaceutical, or regulated manufacturing.

· Prior QA leadership or supervisory experience required.

· Strong knowledge of FDA regulations, cGMPs, and cosmetic/OTC compliance.

· Excellent communication, problem-solving, and organizational skills.

PHYSICAL REQUIREMENTS

· Ability to work in office and manufacturing environments.

· Ability to stand, walk, and sit for extended periods.

· Ability to lift up to 25 lbs and wear required PPE.

Salary Range:$70K to $85K.

At Prime, we believe that a diverse, equitable and inclusive workplace makes us a more relevant, more competitive, and more resilient company. We welcome people from all backgrounds, ethnicities, cultures, and experiences. Prime is an equal opportunity employer.

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