QC IT Systems Specialist
(Remote based position)
Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success.
PPD has an exciting opportunity within it's FSP business for a QC IT Systems Specialist who is specialist in Empower and SampleManager LIMS to join us exclusively for one of our strategic pharmaceutical partners who are based in Ireland. PPD works in collaboration with this pharmaceutical partner; you will be dedicated to the client projects, processes, working within their Global teams and systems on behalf of PPD.
As QC IT Systems Specialist you will be 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.
This requires partnering with all levels of laboratory personnel, Information Technology, analytical support teams, and Quality Assurance to ensure processes are designed and maintained for lab systems to meet business and agency requirements with operational efficiency in mind.
Duties & Responsibilities:
- Create and maintain lab systems by executing the appropriate change management process to support laboratory testing activities and to ensure business, project and/or investigation/CAPA timelines are met.
- Support review of change controls associated with lab systems, identify system impact, and develop appropriate change actions required to support implementation of the change, including impact to interfacing systems.
- Execute and document appropriate change control and/or verify changes executed by a team member are accurate associated within the lab system.
- Review method/specification changes and work with appropriate SMEs to assess impact to lab systems data set up
- Test changes/enhancements through dry runs and receive feedback from lab users, when required.
- Setup verification testing as appropriate for the lab system.
- Execute User Acceptance Testing for system functionality changes.
- Communicate impact of lab system changes to integrated systems areas (i.e. trending system, MES, etc).
- Collaborate/liase with appropriate laboratory, manufacturing, analytical support and/or site/global IT teams to ensure needs and requirements are accurate in the lab systems.
- Evaluate, recommend and implement processes to improve compliance and the efficiency of laboratory testing operations (i.e. visibility to testing queues, testing metrics monitoring, etc.) to support product release, new products, and key performance indicators/lean lab metrics.
- Contribute to the development/maintenance of processes for effective communication/visual dashboards for lab system work in progress and tracking team metrics.
- Assist with compiling/tracking team metrics.
- Author, revise, and/or review procedural documents, such as SOPs and WIs and contribute to the development of associated training content.
- Train users and less experienced staff on use of lab systems.
- Provide ad hoc support to users for issues/questions on the lab system.
- Communicate technical issues and activity status updates to team members/direct management.
- Process user account requests for system access.
- Maintain up to date knowledge on lab system functionality and apply functionality to improve system use and ensure efficient user experience within the systems.
- Participate on/Lead teams in support of business process improvements/operational excellence.
- Assist with management of the day to day activities and prioritization of work, as business needs require.
- Present information at group/department meetings.
- Provide support for internal compliance and regulatory agency inspections as required.
Education and Experience:
- Min. Bachelor's Degree in relevant scientific, computer or engineering program area
- Min 3 years relevant experience
Candidate must have
proficient experience in the administration and development of lab systems and the
understanding of system interfaces and impact of changes on each other. Systems must
- Empower - Custom Field and Custom calculations (essential)
Empower SampleManager LIMS - static data/master data administration (essential)
- LIMS Static Data
- MODA, CIMS, etc., understanding of system interfaces and impact of changes to each other.
- Advanced knowledge and in depth understanding of analytical techniques preferred.
- Proficient/Advanced knowledge and understanding of Microsoft Office Applications
- Demonstrated ability to work independently to complete assignments within defined time constraints.
- Ability to execute changes in the lab system independently, proactively identify problems, troubleshoot issues, and develop potential solutions.
- Respond to system issues and troubleshoot to identify cause.
- Ability to interpret and apply cGMPs, regulatory requirements, and industry best practices.
- Ability to exercises judgment and makes sound decisions within broadly defined practices and policies. Apply appropriate notification to management as appropriate.
- Demonstrated ability to effectively train and assist other less experienced individuals
At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.
As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.