Quality Assurance Manager

Are you a QA leader who likes to take initiative and make decisions that drive quality results?

Kutol Products Company is a growing manufacturer of liquid skin care products, including OTC drugs, cosmetics and medical devices operating out of our silver LEED certified manufacturing plant in Sharonville, Ohio. To support our purpose of clean hands for a healthy world, we are seeking a QA professional to provide leadership that ensures the cGMP and regulatory compliance of our products, processes, and documentation. This position manages our Quality Assurance team including technicians, a specialist, incoming inspection, and label personnel across a three-shift operation.

Additional Key Responsibilities of the QA Manager include:

• ensuring global regulatory compliance pertaining to the FDA, Health Canada and Australia;
• performing risk assessments and spearheading our internal audit program;
• authoring, revising, reviewing and approving cGMP documentation including SOPs, labels, material and component specifications, master records, deviations, validation protocols and supplier agreements;
• overseeing periodic documentation and annual product review processes;
• assisting with supplier approvals and performing FDA and Canadian product registrations;
• assisting with qualifications and validations of equipment, processes and methods;
• reviewing manufacturing records and disposition of finished product;
• supporting or performing investigations to determine root causes and CAPAs.

Requirements

We’ll be looking for candidates with a Bachelor’s in a scientific discipline and 5 or more years of OTC drug and cosmetic experience, along with demonstrated success in a managerial or supervisory role. Extensive knowledge of US and Health Canada drug product and cosmetic cGMP requirements is needed with the ability to interpret, analyze and make independent decisions.

Benefits

A competitive salary with a full benefit package is on the table, with an additional opportunity for profit sharing when we succeed as a team. When you combine that with our shared-fate culture, and 100+ years’ of company stability, we believe Kutol is a great place to work! To learn more about us, check out our website at http://www.kutol.com