Quality Assurance Engineer

Kindeva Drug Delivery

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

Why Kindeva?

• Purpose-driven work environment
• Significant growth potential
• Collaborative team culture
• Direct impact on patient care
• Industry-leading innovation

The Impact You Will Make:

Transform Lives Through Innovation Join a rapidly expanding pharmaceutical CDMO where your work directly impacts patient health outcomes worldwide. In this position, you will play a crucial role in supporting quality involvement and oversight during pharmaceutical development and manufacturing, particularly related to the design and qualification of new equipment.  Observe critical operations and procedures as they occur, audits documentation, records activities and keeps management informed on quality issues. By collaborating with cross-functional teams, you'll directly contribute to the improvement in patient outcomes around the world.

At Kindeva – Lexington, KY, we're not just making products – we're manufacturing life-saving nasal spray medications that make a difference.

Growth Opportunity

Our Lexington facility is experiencing exponential growth, offering exceptional opportunities for professional development and advancement. Join us during this exciting expansion phase and grow your career while contributing to meaningful healthcare solutions.

Responsibilities:

• Lead facility transformations, equipment changes, and system implementations, including quality oversight of all testing and validation processes
• Drive comprehensive quality systems development, including investigations, CAPAs, and compliance protocols
• Ensure DEA, FDA, and EMA compliance through continuous improvement initiatives
• Manage compliance assessments, regulatory inspections, and customer audits
• Review and approve critical cGMP documentation and validation protocols
• Provide expert quality guidance to senior leadership
• Develop compliance metrics and collaborate with internal/external stakeholders
• Lead cross-functional quality initiatives and special projects

Qualifications:

Required

• Bachelor’s degree in a scientific discipline
• Looking for 5+ years of cGMP experience, with at least 2 years in an engineering or quality assurance role.
• Ability to assess problems, to identify solutions, to plan and implement necessary changes
• Knowledge of cGMP regulations and validation principles
• Ability to work well in a team-oriented environment
• Well-developed communication and technical writing skills
• Qualified to work with controlled substances

Preferred:

• Experience in the Pharmaceutical Industry.

Join our One Team mission of manufacturing more tomorrows. Your expertise will help ensure better health and well-being for patients worldwide.

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