Responsible for the oversight, deployment, administration, maintenance, and support of laboratory applications, learning management systems, and associated standalone and enterprise systems within a regulated pharmaceutical laboratory environment. Serves as the SM LIMS Site Subject Matter Expert and supports compliant administration of SF LMS.
Essential Functions:
- Complete maintenance and administration responsibilities for validated laboratory and learning management applications. Examples include Empower 3 Chromatography Data Software, SampleManager LIMS, SF LMS, and standalone laboratory systems.
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Perform Site Subject Matter Expert duties for laboratory applications, including troubleshooting, adding and removing users, managing roles and permissions, completing periodic user access reviews, generating reports, rebooting LAC/e boxes for analysts, and performing other activities required to support laboratory applications.
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Complete all LIMS Site SME specific responsibilities as outlined in PSG Global and site Standard Operating Procedures.
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Provide SM LIMS functional and administrative support, including system configuration support, user and role administration, workflow troubleshooting, master data support, issue investigation, periodic reviews, reporting, and coordination of system changes.
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Participate in internal and external audits (when applicable), including regulatory and customer audits, including developing responses to observations.
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Participate in CFR21 part 11 compliance and reg activities.
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Build and maintain technical trouble shooting body of knowledge library.
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Participate in laboratory application related PPI initiatives.
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Report deviations and recommend and implement preventive and corrective actions to continuously improve the quality of laboratory promptly.
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Coordinate with vendor and Global IT on system upgrades, maintenance, and troubleshooting; track issues and ensure resolution.
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Perform administrator duties on standalone systems (such as FTIR, AA) such as add/ remove users, troubleshooting access issues and annual user reviews and reports
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Establish and maintain communication platforms between the LIMS and designated laboratory instrumentation.
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Perform required periodic maintenance on the various LIMS installations.
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Work closely with IT to maintain network communication between the instruments and Sample Manager LIMS. Help maintain computer networks and network infrastructure required for LIMS.
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Support the installation, implementation and maintenance of the laboratory applications.
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Establish and maintain communication between the Sample Manager LIMS and other site data systems (i.e.: SAP), as required.
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Streamline and consolidate legacy processes/systems into Sample Manager LIMS.
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Perform monthly and yearly review of excel validated spreadsheets.
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Provide end user training and support as needed
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Maintain a safe working environment and report potential hazards.
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Perform alternating or rotating shift work (as required)
REQUIRED QUALIFICATIONS
Education:
Bachelors Degree in Science or Computer Science or similar field of study. Equivalent combinations of education, training, and relevant work experience may also be considered.
Experience:
Minimum 10 years laboratory experience.
Minimum 6 years laboratory experience in use of lab software applications (example include: Empower, Chromeleon and LIMS application), Knowledge of 21CFR Part 11 compliance.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills and Abilities:
Excellent verbal communication and written, with active listening and summarization skills. Sound knowledge of Good Manufacturing Practices. Sound understanding of Standard Operating Procedures. Business process knowledge of Quality Management, Lab Operations, and Lab Information Management Systems. Ability to make quality decisions. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English language.
Standards and Expectations:
Follow all Environmental Health & Safety Policies and Procedures. Work harmoniously with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems SOP's and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines of deliverables in a proactive manner. Consistently strives to improve skills and knowledge in related field.
Standards and Expectations:
Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems SOP's and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field.
Physical Requirements:
Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.
Disclaimer:
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
