QC Lab Systems Specialist

QC LAB SYSTEMS SPECIALISTPHOENIX, AZ This is a HYBRID role - 2 positions open Project Description:

• This position is responsible for providing technical support in the development and maintenance of various QC lab systems user workflows to support various site manufacturing, stability, method transfer and non-routing testing activities to ensure compliance with procedures, methods, specifications, sampling plans, and data reporting requirements for raw material, water, microbial, biologics drug substance and/or biologics drug product testing.
• Create and maintain master data/static data in lab systems by executing the appropriate change management process to support laboratory testing activities.
• Execute standardization plan and contribute to identifying opportunities to standardize.
• Execute and document appropriate change control associated with the application, which requires knowledge of system interfaces and impact to each other.
• Consult with more experienced team members as needed to understand system interfaces.
• Collaborate with appropriate laboratory personnel to ensure laboratory needs and requirements are accurate in the lab system setup.
• Test changes/enhancements through dry runs and receive feedback from lab users, when required.
• Execute User Acceptance Testing for system functionality changes.
• Contribute to implementing lab system improvements to enhance compliance and the efficiency of laboratory operations (i.e. testing queues, testing metrics monitoring, etc.) to support product release, new products, key performance indicators/lean lab metrics.
• 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.
• Author, revise, and/or review procedural documents, such as SOPs and WIs and contribute to the development of associated training content.
• Assist with integration and training of users and less experienced staff on use of the lab systems.
• Communicate technical issues and activity status updates to team members/direct management.
• Participate on a project team and execute key deliverables.

• Bachelor's degree preferred and/or in relevant scientific, computer, or engineering program with at least 1-3 years of experience in the biopharmaceutical industry, or equivalent combination of education and experience.
• Working knowledge and understanding of analytical techniques preferred.
• Basic knowledge/experience with at least one lab system, such as Empower, LES, LIMS, MODA, CIMS, etc. preferred.
• Basic knowledge of databases and/or Microsoft Office Applications (Access, Excel, Project, PowerPoint, SharePoint, Teams Word) and/or other relevant software programs, preferred.
• Ability to execute changes in the lab systems with direction from senior team members.
• 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.
• Demonstrated problem solving ability, attention to detail, and analytical 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.
• Ability to receive and act on assignments that do have a clearly defined process
• Ability to work independently or as part of a team.
• Must be flexible to adjust workload to adapt to changing business needs.