Senior Quality Assurance Engineer

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 At Kindeva Lexington, KY, we're not just making products – we're manufacturing life-saving nasal spray medications that make a difference.   The Impact You Will Make: Transform Lives Through Innovation Join a rapidly expanding pharmaceutical CDMO where your work directly impacts patient health outcomes worldwide. This position ensures the seamless coordination of office operations, procedures, and resources to enhance organizational efficiency.  This role is responsible for providing quality involvement and oversight during pharmaceutical development and manufacturing, particularly related to the design and qualification of new equipment. We are looking for key talent who can observe critical operations and procedures as they occur, audit documentation, record activities, and manage the communication process with the site leadership team on quality issues. The ideal candidate possesses at least seven years of cGMP experience, including a minimum of two years in an engineering or quality assurance role, along with a bachelor's degree in a scientific discipline or an equivalent combination of education and experience. 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: Support the induction and management of changes of facilities and equipment including but not limited to: FAT, SAT, URS, etc. for new equipment, facility expansion and commissioning, facility decommissioning, and laboratory or facility movement.  Oversite of New E-system Implementation Supports the development and maintenance of Quality Systems as appropriate including leading and supporting manufacturing investigations, change controls, CAPAs, product complaint investigations, etc. Leads continuous improvement objectives to assure compliance with DEA, FDA, and EMA regulations. Advises senior management on findings and recommendations related to quality issues. Reviews, and approves cGMP documentation including procedures, validation protocols, development reports, and other related documents. Develops and maintains metrics and trending reports for Compliance-related activities. Performs activities associated with various one-time or on-going projects. Collaborates with departments and external suppliers regarding quality concerns. Participates and/or coordinates Compliance Assessments of departments as necessary (GXP, Part 11, etc.). Supports regulatory inspections and customer audits. Assists Manager with daily and project activities as needed. Other duties as assigned.   Qualifications: Bachelor’s degree in scientific discipline or equivalent years of experience. At least 7 years 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 Join our One Team mission of manufacturing more tomorrows. Your expertise will help ensure better health and well-being for patients worldwide.   # LI-Onsite