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The QC Systems Management team is responsible for implementing and maintaining electronic systems that support operations in the quality control (QC) laboratories.
This position is responsible for building and sustaining electronic systems that support the Quality Control laboratories. Primary duties include conversion of electronic notebook methods, Empower updates, LIMS static data builds, configuration of system reports, and updates to Discoverant.
• Create and maintain QC Systems by executing systems change management process to support routine laboratory testing, method transfers, and method validation activities.
• Conversion of electronic notebook methods, Empower updates, LIMS static data builds, configuration of system reports, and updates to Discoverant.
• Collaborate with appropriate laboratory personnel to ensure laboratory needs and requirements are accurate within the system data setup.
• Test changes/enhancements through dry runs and receive feedback from lab users, when required.
• Develop/Execute User Acceptance Testing for system functionality changes.
• Contribute to implementing system improvements to enhance compliance and the efficiency of laboratory operations (i.e. work in progress, metrics monitoring, etc).
• Author, modify, and review standard operating procedures associated with laboratory support systems.
• Assist in the facilitating, authoring, review, and verification of QC Systems change management documentation, laboratory technical documents, General Knowledge Units (GKU), Job Function Training (JFT) and SOPs, including creating, formatting, proofreading, issuing and tracking, to ensure business, project and/or investigation/CAPA timelines are met.
• Maintain processes for effective communication of laboratory operations, including administration and organization of SharePoint sites, to provide visibility to department activities, including, but not limited to, ongoing operations to support product release or new products, key performance indicators/metrics, and project updates.
• Process user account requests for system access.
• Maintain up to date knowledge on functionality and apply knowledge to enhance site use of the system to ensure efficient operations.
• Participate on teams in support of business process improvements/lean principles/operational excellence.
• Provide ad hoc support to users for issues/questions on the system.
• Train users and less experienced staff on use of the QC Systems.
Specific Knowledge, Skills, Abilities, etc:
• Knowledge/experience in QC laboratory operations preferred.
• Working knowledge of databases, laboratory applications, including LIMS, Electronic Notebook, Discoverant, Maximo, DCA, QUMAS, and various laboratory instrumentation systems (i.e. Empower) and techniques (i.e. HPLC, spectroscopy, ELISA, Bioassay), preferred.
• Specific knowledge of interfaces between Empower and Electronic Notebook systems and/or LIMS and Electronic Notebooks, including impact to each other, highly desired.
• Ability to execute changes in the QC Systems with direction from senior team members.
• Ability to take initiative and prioritize objectives from multiple projects; adhere to scheduled timelines while maintaining flexibility, independently or as part of a team.
• Demonstrated problem solving ability, attention to detail, and analytical thinking skills.
• Ability to interpret and apply cGMPs, regulatory requirements, and industry best practices.
• Interpersonal, oral and written communication skills are essential. Must contribute to a team based, collaborative and positive environment, clarity of purpose and high commitment to business goals.
• Basic knowledge of Microsoft Office Applications (Access, Excel, Project, PowerPoint, Word) and/or other relevant software programs, preferred.
QC Laboratory Systems Analyst:
Bachelor's degree in relevant scientific, computer, or engineering program with at least 1-3 years' experience in the biopharmaceutical industry, or equivalent combination of education and experience.
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