QC Lab Systems Specialist
24 hours ago
Role Overview:
This position is a technical support role within the Lab Digital Sciences organization QC Digital Systems Technical Support pillar that is responsible for building and maintain LIMS master data, following developed standards in direct support of Global Quality Control Operations that are responsible for testing to support new product introductions, site manufacturing plans, global stability programs, analytical method technical transfer and other non-routine testing activities. As a LIMS Assistant Scientist, you will ensure compliance with established procedures, methods, specifications, sampling plans, and data reporting requirements that include, and may not be limited to, raw material, water, microbial, biologics drug substance and/or biologics drug product testing, while additionally providing ad hoc technical support to QC labs users to ensure operational and business needs are addressed to ensure timely completion of product release and stability testing to ensure supply of medicines to our patients.
Key Responsibilities
- Create and maintain master data/static data in lab digital systems by following established standards and executing the appropriate change management process to support laboratory testing activities.
- Execute and document appropriate change control associated with the Enterprise system 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 (UAT) 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.
- 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.
- Communicate technical issues and activity status updates to team members/direct management.
- Participate on relevant project teams and execute key deliverables as assigned.
Qualifications & Experience
- Minimum 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.
- Basic knowledge and understanding of analytical techniques preferred.
- Basic knowledge in at least one lab system (LIMS, LES, Empower, MODA, CIMS, etc.) or has knowledge of systems / databases/ programming.
- 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 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
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
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