LES Lab Support Analyst US
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
Overall responsibility for maintaining and supporting the quality control (QC) computerized lab quality systems. Tasked with ensuring compliance and qualifications of the lab systems in accordance with industry best practices, FDA standards, and GXP regulations. Managing and directing the daily work of project resources and/or contractors in the LES group that support the lab systems.
- Analyze and troubleshoot hardware, software, and network-related problems relying on proven techniques for analysis and evaluation.
- Assist in configuration, implementation and administration of servers and related applications, including VMWare and Citrix, to provide a responsive and consistent computing environment.
- Manage and maintain periodic data backup for servers, PCs and storage devices.
- Install new software releases and system upgrades.
- Perform Quality management activities related to qualification, GXP Validation, and change management.
- Work with Business Process Owners and Quality Assurance to facilitate system changes including risk and impact assessment, product enhancements, and process improvements. Create customized login scripts, batch files, and Windows configuration utilities to make compliant software that does not conform to Seqirus GMP specifications.
- Manage validated servers including GMP Data Server to ensure high availability and data integrity. Assist with data retrieval and reporting from flat file and database repositories.
- Provide technical skills to write computer system life cycle, validation, and decommissioning documentation in accordance to GAMP 5 framework and regulatory agencies’ requirements and procedures.
- Track and execute computer system periodic reviews, user account reviews and other computer system compliance processes as assigned.
- Support Users with laboratory information system needs
- Prepare Computer System Validation protocols, SOPs, procedures, log books etc.
- Assist with IQ, OQ and PQ on laboratory instrument software.
- Create, update, audit, and modify documentation as required.
- Engage and escalate to vendors for service restoration.
- Set up, configure, troubleshoot, and maintain QC and manufacturing lab quality systems, ensuring compliance with FDA standards and industry best practices surrounding CFR 21 Part 11 and Annex 11 regulations.
- Provide diagnostic support for both hardware and software, interfacing with other support teams and vendors to resolve incidents in a timely manner. Produce problem resolution documentation and perform root cause analysis.
- Create and maintain application support documents including SOPs, technical configurations, design and validation documents, and user training modules while reconciling compliance with federal regulations as well as local and global company policies and procedures.
- Conduct emergency maintenance activities and system reviews (security, audit trail, and data integrity) to ensure the general health and availability of GxP computer systems.
- Assist with efficiency management and continuous process improvement of lab systems, implementing new features, software, or technologies to enhance operational performance
- Bachelor’s Degree in associated field.
- 3+ years’ experience in a regulated environment
Knowledge, Skills & Competencies:
- Understanding of GAMP 5 framework
- Experience in writing Validation Documents, Risk Assessments, Verification plans and test scripts.
- Experience with current Internet technologies/ protocols are a plus.
- Experience in Waters Empower, QMS and LIMS systems are preferred
- Experience in Analytical and Pre-Formulation and Formulation system software is preferred
- Thorough knowledge of Windows XP, 7, and 10, Server 2008, 2012, and 2016, Active Directory, storage and backup devices, VMWare, Routers, Switches and other solutions.
- Knowledge in server, storage and virtualization standards, techniques and tools. Acronis knowledge a plus.
- Knowledge and support of standard software packages including Microsoft Office and Adobe productivity tools.
- Strong written & verbal communication. Effectively collaborate with peers, cross-functional teams and users across the organization to achieve end-to-end product and process quality.
- Strong Analytical/problem solving skills. Must be organized and able to multitask.
- Able to work independently and as a team member in a high performance environment.