What are the responsibilities and job description for the Quality Assurance Manager position at KCO Resource Management?
We’re working with a well-established, leading manufacturer of personal care and household cleaning items that is searching for a Quality Manager. This person will ensure compliance with FDA OTC drug and cosmetic regulations, GMP standards, and internal quality requirements. The QA Manager will drive a culture of quality, maintain inspection readiness, and lead continuous improvement initiatives. This role will report to the Director of Quality Systems.
Location: Long Island, NY
Job Responsibilities:
- Develop, implement, and maintain the Quality Management System covering document control, CAPA, deviation management, audits, and supplier qualification.
• Ensure compliance with FDA OTC regulations.
• Review and approve GMP documentation including master batch records, production records, testing protocols, and validation documents.
• Lead investigations, root cause analysis, and corrective/preventive actions.
• Prepare for and manage internal, supplier, and external (FDA or customer) audits.
• Support new product introductions ensuring compliance with quality and regulatory requirements.
• Oversee supplier quality performance, raw material specifications, and incoming inspection processes.
• Collaborate cross-functionally with manufacturing, R&D, packaging, and regulatory teams to ensure product quality at every stage.
• Maintain calibration and maintenance programs for testing and inspection equipment.
• Lead, train, and develop the QA team, fostering a proactive quality culture.
Required Skills/Qualifications:
- Bachelor’s degree in Microbiology, Chemistry, Life Sciences, Engineering, or related discipline required.
- 5 years of progressive experience in Quality Assurance or Quality Systems within FDA-regulated industries.
- 2 years of leadership experience managing quality teams and laboratories in a cGMP-compliant manufacturing environment, ideally within OTC or personal care products.
- Strong knowledge of FDA OTC regulations, GMP, and quality systems management.
- Excellent communication, leadership, and problem-solving skills.
- Familiarity with root cause analysis, CAPA management, and continuous improvement tools.
- ASQ or equivalent quality certification is a plus.
- Effective communicator.
