Career Opportunities

Manager, Quality Control Logistics

Posted on:	Monday, September 11, 2023
Organization:	LOTTE Biologics
Location:	East Syracuse, NY
Description:	Responsibilities To help us meet our mission LOTTE Biologics is in need of a Manager, Quality Logistics to support the onsite commercial manufacturing facility, and provides testing as a third party QC laboratory. The Manager, Quality Control Logistics (Quality Shared Services (QSS)) manages QSS staff to enable daily operations in the testing laboratories to meet customer needs. Additionally, this position directs and supports method performance monitoring and data reporting activities. This position requires partnering with QC Operations, IT Quality Systems, and Quality Assurance as well as other internal and external customers to ensure efficient processes are designed/maintained to meet business requirements. Provide technical and strategic leadership in the development and maintenance of one or more areas including, but not limited to QC Data Analytics and Sample Submission Operations (SMO). Responsible for management and compliance of the QC data analytics program applications and operational activities. Responsible for overseeing management of regulatory reserve program, including drug substance and raw materials. Responsible for ensuring GMP compliance and performance of Sample Submission Operations responsible for storage, shipping logistics and related activities for Quality Control. Responsible for ensuring compliance with QC systems use and sample management requirements for raw material, water, microbial, biologics drug substance and biologics drug product testing. Provide leadership and guidance to ensure compliance with Site procedures and cGMP/GLP Provide leadership and guidance in the management of contract laboratory testing to support the timely release of product while ensuring good customer relationship/communication. Collaborate with IT Quality Systems team to develop processes in applicable QC system applications to support laboratory testing activities, monitoring, and reporting department metrics. Participate/support regulatory inspections and responses; lead tours and provide process overview of supervised areas with regulatory agency inspectors and internal auditors. Provide investigational support associated with sample handling and applicable data analytics applications and method performance. Ensure safe and compliant operations as well as overall inspection readiness of supervised areas. Recruit and develop high performing and diverse team. Create an environment for continued learning and innovation.
Requirements:	Education/Experience/ Licenses/Certifications: Minimum B.S. degree in a scientific area with 8 to 10 years’ experience, or M.S. degree with 4 years’ experience. Experience working in a cGMP laboratory preferred. Demonstrated leadership ability with excellent communicative skills to lead a team based, collaborative and positive environment, with clarity of purpose and high commitment to business goals. Demonstrated working knowledge of laboratory database applications (i.e. LIMS, LES, MODA) and various laboratory instrumentation systems and techniques preferred. Demonstrated knowledge in the field of data analysis. Knowledgeable in regulatory requirements (i.e. US, EU, USP) and industry best practices and prior experience supporting regulatory agency inspections preferred. Self-directed with a high degree of professional integrity, very organized, and detail oriented. Excellent problem-solving ability and analytical/critical thinking skills. Ability to take initiative and prioritize objectives from multiple projects; adhere to scheduled timelines while maintaining flexibility, independently or as part of a team. Advanced knowledge with Microsoft Office Applications (Access, Excel, Project, PowerPoint, Word) and/or other relevant software programs such as JMP, PowerApps,etc. Specific Knowledge, Skills, Abilities, etc: Expert level applied knowledge and in depth understanding of analytical techniques and data evaluation, preferred. Demonstrated leadership ability. Self-directed with a high degree of professional integrity, very organized, and detail-oriented. Excellent problem solving ability, attention to detail, and analytical/critical thinking skills. Ability to independently, proactively troubleshoot within QC system applications. Strong interpersonal, oral and written communication skills are essential, including the ability to communicate at all levels with clarity and precision. Ability to take initiative and prioritize objectives from multiple projects; adhere to scheduled timelines while maintaining flexibility, independently or as part of a team. Ability to interpret and apply cGMPs, regulatory requirements, and industry best practices. Must contribute to a team based, collaborative and positive environment, clarity of purpose and high commitment to business goals. Demonstrated ability to effectively train and assist other less experienced individuals.

View All Career Opportunities »