QC LIMS Specialist

Lonza•Houston, TX

1d•Onsite

About The Position

QC LIMS Specialist Location: This is an on-site position located in Pearland, TX The purpose of this role is to have responsibility for the operational support of the LIMS (Laboratory Information Management System). This task includes application development and support, system administration with a focus on the LIMS systems. The position focuses on optimal support for system users and GMP compliance of the system. In this position, the practical expertise from the laboratory is used to generate ideal solutions for digital logging within the LIMS system. What you will get: A competitive compensation. In addition, below you will find a comprehensive summary of the benefits package we offer: Performance-related bonus. Medical, dental and vision insurance. 401(k) matching plan. Life insurance, as well as short-term and long-term disability insurance. Employee assistance programs. Paid time off (PTO). Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge. What you will do: Implements program upgrades, reports problems, supports Laboratory, Production and Quality Assurance personnel with application usage. Creates and maintains application procedures and system configuration documents. Maintains stored data and compliance documentation for all related software programs including, validation protocols, critical system change requests, and system functional requirements. Works with subject matter experts (SMEs) to clarify and document user requirements. Manages application validation and change control activities. Performs and/or reviews and verifies data modification and change controls as requested by applications end users. Performs software validation/changes. Executes software validation documentation and writes, executes and reviews change control documentation. Writes and/or reviews and verifies reports requested by QA, Technical Support and Operations. Reviews/approves software documentation prepared by LIMS personnel. Maintains, modifies/upgrades, and troubleshoots programs and upgrades, which includes but not limited to: creation/modification of product specifications, analyses, and calculations; systems problems as they occur; and Screen Maintenance Evaluates product enhancements and capabilities as required. What we are looking for: Serves as one of the team members to answer LIMS and TrackWise functionality and business process questions, utilizes in-depth understanding of the limitations of the application and how it may be changed to assess issues and define solutions; has experience with coding and programming within a LIMS-like system and understands functionality at the technical level Translates functional business requirements into technical requirements and specifications, analyzes and assesses business impact and urgency of incidents/problems affecting application availability, function and/or performance to develop work priorities. Resolves Application Incidents and problems impacting local business operations according to business impact priority. Troubleshoots system-related problems, tracks and documents incidents and works with IT to escalate issues to vendor support; provides day-to-day end user support. Delivers one-on-one or group training to individuals, as needed, on systems that includes not only information on the process, but the opportunity to practice, and monitors the effectiveness of training efforts to identify opportunities for improvement. Works closely with end users to spot trends in terms of need for additional training or changes that would improve the end-user functionality. Ensures documentation of training is created and collected. About Lonza: At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences? Apply now.

Requirements

Serves as one of the team members to answer LIMS and TrackWise functionality and business process questions, utilizes in-depth understanding of the limitations of the application and how it may be changed to assess issues and define solutions; has experience with coding and programming within a LIMS-like system and understands functionality at the technical level
Translates functional business requirements into technical requirements and specifications, analyzes and assesses business impact and urgency of incidents/problems affecting application availability, function and/or performance to develop work priorities.
Resolves Application Incidents and problems impacting local business operations according to business impact priority.
Troubleshoots system-related problems, tracks and documents incidents and works with IT to escalate issues to vendor support; provides day-to-day end user support.
Delivers one-on-one or group training to individuals, as needed, on systems that includes not only information on the process, but the opportunity to practice, and monitors the effectiveness of training efforts to identify opportunities for improvement.
Works closely with end users to spot trends in terms of need for additional training or changes that would improve the end-user functionality.
Ensures documentation of training is created and collected.

Responsibilities

Implements program upgrades, reports problems, supports Laboratory, Production and Quality Assurance personnel with application usage.
Creates and maintains application procedures and system configuration documents.
Maintains stored data and compliance documentation for all related software programs including, validation protocols, critical system change requests, and system functional requirements.
Works with subject matter experts (SMEs) to clarify and document user requirements.
Manages application validation and change control activities.
Performs and/or reviews and verifies data modification and change controls as requested by applications end users.
Performs software validation/changes.
Executes software validation documentation and writes, executes and reviews change control documentation.
Writes and/or reviews and verifies reports requested by QA, Technical Support and Operations.
Reviews/approves software documentation prepared by LIMS personnel.
Maintains, modifies/upgrades, and troubleshoots programs and upgrades, which includes but not limited to: creation/modification of product specifications, analyses, and calculations; systems problems as they occur; and Screen Maintenance
Evaluates product enhancements and capabilities as required.
Serves as one of the team members to answer LIMS and TrackWise functionality and business process questions, utilizes in-depth understanding of the limitations of the application and how it may be changed to assess issues and define solutions; has experience with coding and programming within a LIMS-like system and understands functionality at the technical level
Translates functional business requirements into technical requirements and specifications, analyzes and assesses business impact and urgency of incidents/problems affecting application availability, function and/or performance to develop work priorities.
Resolves Application Incidents and problems impacting local business operations according to business impact priority.
Troubleshoots system-related problems, tracks and documents incidents and works with IT to escalate issues to vendor support; provides day-to-day end user support.
Delivers one-on-one or group training to individuals, as needed, on systems that includes not only information on the process, but the opportunity to practice, and monitors the effectiveness of training efforts to identify opportunities for improvement.
Works closely with end users to spot trends in terms of need for additional training or changes that would improve the end-user functionality.
Ensures documentation of training is created and collected.