Manufacturing Specialist

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will MakeThe Manufacturing Specialist is responsible for direct support of process improvement and compliance directives associated with the manufacturing activities at the KDD Lexington facility. Direct ownership of process deviation investigations corrective/preventive action (CAPA) and change control. Manufacturing Batch Record and SOP revision and Responsibilities: Quality Systems: Deviation / CAPA / Change ControlCollaborate effectively with Quality Assurance and technical subject matter experts from other support departments to ensure Manufacturing commitments are completed in a compliant of Quality System work such as deviations complaints OOS OOT etc. Execute on-the-floor investigation triage and perform root cause process product and equipment related validation and stability protocols and reportsTechnical review of Batch Records SOPs and manufacturing processes. Develop and implement process improvementsRequired to work with some supervision by senior staff and with other departmental or non-departmental in Manufacturing Process Improvement Teams and leads continuous improvement initiatives on the manufacturing change management strategies to engage communicate train and support Manufacturing Technician staffOther assigned responsibilities as established by QualificationsHS Diploma or equivalent. 3 years GMP experience required. BS degree in Engineering Business/Operations or related discipline preferred. Knowledge of GMP regulations and regulatory requirements in pharmaceutical to make sound decisions regarding compliance-related issues with moderate have strong attention to to manage multiple priorities and tasks in a dynamic communication skills (written and verbal) and strong organizational skills. High level of personal/departmental accountability and with programs such as Access Excel ERP Power BI Power Aps and an electronic document management to work in a team environment and to work within that team to maximize efficiency and manufacturing continuous improvement experience preferred.