QC LIMS Senior Specialist
QC LIMS SENIOR SPECIALIST
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- Title: QC LIMS SENIOR SPECIALIST
- Location: Houston, TX
- Industry: Pharmaceutical
- Hours: Monday-Friday 8AM - 5PM
- Salary: $65hr (Paid Weekly)
- Employment Type: Long Term Contract
Responsible 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.
- Bachelor of Science in Computer Science / programming, or Associates Degree in science, and/or 5 years hands-on experience.
- Minimum five (5) years hands-on experience with LIMS software / system usage, and/or laboratory experience.
- Skilled handling of common software applications (MS Office) and a keen interest in working with computer-based systems are required, user and/or specialist knowledge of LIMS and other pharmaceutical/laboratory software (e.g. Documentum) are an advantage, good technical comprehension and very good organizational skills round off your profile.
- 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.
- Keep current of technologies, and technological advances associated with Labware LIMS programs.
- Clear communication in English (written, oral), organizational skills, independence, structured thinking skills, teamwork, customer orientation
- Self-organizing, strong skills to track problems to solution
- Performs other duties as assigned
- Serves as one of the go to persons 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.
- Translates functional business requirements into technical requirements and specifications.
- Authors and reviews SOP s.
- 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 and works with IT to escalate issues to vendor Support.
- Tracks and documents incident and problem-solving actions and results through to completion.
- Provides account administration and end-user support.
- Functions as system administrator with 24-hour call for notification of business critical issues.
- Delivers one-on-one or group training to individuals on systems that includes not only information on the process, but the opportunity to practice.
- 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.
- Performs other duties as assigned
- Strong technical skills in IT systems including specific working knowledge of LIMS
- Basic Outlook skills as evidenced by creating and sending messages, working with address books, message handling, creating and using personal folders, scheduling appointments, working with meeting requests and managing tasks.
- Basic Microsoft Word skills as evidenced by the ability to produce basic business letters and simple tables and charts; as well as check spelling, set tabs, change page orientation, sort, save, open and organize electronic files.
- In-depth knowledge of cGMP principles. Able to identify breach of cGMP principles and provide suggested corrective actions.
- Considered Subject Matter Expert on routine and select specialized methods.
- Proficient in the use of spreadsheets, databases, and word processing software.
- Prior experience with SAP and TrackWise a plus