KCO Resource Management
Quality Manager
Location: Long Island, NY
Pay Range: $140,000 / yr – $150,000 / yr
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 reports to the Director of Quality Systems.
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.
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.
Benefits: Medical insurance, Vision insurance
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Pay Range: $140,000 / yr – $150,000 / yr
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 reports to the Director of Quality Systems.
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.
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.
Benefits: Medical insurance, Vision insurance
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