Quality Assurance Supervisor- New York City
Prime Matter Labs · New York, New York, United States · 1 mo ago
On-siteInformation Technology$70k–$85k/yrFull-time
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.
PAY
Salary Range: $70K to $85K.