About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Overview:
The Laboratory Information Systems (LIMS) Specialist is responsible for supporting site business in static data management within the LIMS platform, complete and review change requests, validate configurations, provide user support, and troubleshoot as needed. S/he will be responsible for implementing approved configuration changes within the LIMS platform as outlined in controlled change management records. The position will also be accountable to support documentation revisions in accordance with governing SOPs to ensure the system and procedures operate in a state of control. The ability to function in a fast-paced, distributed team environment, and communicate effectively is essential to success.
This position is responsible for ensuring that the LIMS system meets the requirements of the LIMS procedures and global data standards.
This is a 6-Months contract role with the possibility of an extension
Primary Responsibilities:
- Act as point-of-contact for LIMS supporting site-based customers including laboratories, IPT areas, and regulatory inspection requests.
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Processes change controls for the LIMS system following applicable procedures.
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Serve as Labware LIMS expert to support/train business users that include performing dynamic data corrections, data extraction/reporting, and lead or support LIMS related investigations.
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Collaborates with the site business to clearly define the request/need including detailed description, scope, supporting documentation, priority, business value, impact, dependencies and translate needs into LIMS requirements.
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Perform site LIMS impact assessment including impact to other functional areas/systems and anticipate risks.
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Work and collaborate with a distributed team including those from the site Laboratories and IPT areas, the shared LIMS execution team at Pune, India, and other technical support teams at site and global (e.g., teams supporting SAP, Instrumentation, Empower etc.).
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Prepare technical assessment of change, generate detailed system requirements, and initiate the change in an electronic repository (site or global change tool) and progress the change through its life cycle. Possess technical skills necessary to execute urgent changes to support business.
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Prioritizes changes by the target due date, builds trust with customers by ensuring on time implementation of changes and drives results by overcoming obstacles.
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Ability to execute LIMS build per requirements and global data standards.
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Responsible for driving and maintaining static data standardization and process harmonization across the GLIMS network.
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Experience with Acceptance Testing procedures, coordinates and supports business requestor /change owner in confirmation of requirements, design, and build. perform technical review of test protocols – pre and post execution.
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Perform technical review and approval of change documents to ensure accuracy, compliance, integrity, completeness, and coordinate site pre-approvals.
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Support the business in the creation and updating of training materials as changes to system occur.
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Complete technical assignments independently once specific objectives have been defined.
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Act as first line of support to troubleshoot incidents reported at site, and work with global support /IT in timely resolution of technical incidents through the standard incident and problem management process. Support may include limited off-hour support to triage batch impacting or events which jeopardize the quality or compliance of manufactured materials.
Education, Skills, and Experience:
Required:
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Bachelor’s Degree or higher in Chemistry, Biological or Computer Science
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A minimum of 4 years of LIMS hands-on experience in a pharmaceutical environment with LabWare LIMS v6 (or higher) static data configuration including developing analyses, product specifications, and calculations.
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In depth knowledge and experience on the Labware LIMS modules, primarily Stability, Lot Management, Standards and Reagents, Environment Monitoring, Project Manager, Storage Location manager, and use of Querying tools.
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Familiarity and/or experience with Labware LIMS Basic to build/update calculations.
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Candidate must have knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products.
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Experience with System Development Life Cycle (SDLC) and Validation requirements ensuring compliance with regulatory requirements.
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Possesses the ability to translate Standards (Data/Process) and "Digital transformation" vision into execution projects
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Exhibit ability to learn new features and functions in LIMS and related systems and can increasingly handle more complex issues and requests
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Ability to build and run SQL queries for Ad hoc reporting/querying
Preferred:
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Experience using Microsoft Word and Excel
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Familiarity with other systems (E.g. SAP, Crystal Reports, Documentation Repositories, Electronic Testing Tools)
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Ability to write UAT scripts and support execution of UAT adhering to SDLC
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Provide inspection support (input into storyboarding, understanding the query, articulate findings)
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Programming experience (E.g. SQL, LIMS Basic)
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Ability to build and run SQL queries for Ad hoc reporting/querying
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Ability to translate Standards (Data/Process) and "Digital transformation" vision into execution projects
