Scientist – Quality Control Laboratory Informatics
About The Position
The Scientist – QC Laboratory Informatics role is responsible for supporting laboratory operations through ensuring that electronic laboratory systems function per intended purpose and use, specifically related to end user functionality and to system compliance with company and regulatory requirements. Responsibilities will initially involve interacting with global and local IT support functions to populate master data, configure systems, and assist with installing and qualifying laboratory IT systems such as LabVantage LIMS, MODA, NuGenesis ELN and SDMS, Empower, and other laboratory systems. The role will evolve into monitoring, execution and maintenance of the Laboratory IT Systems for the QC laboratory with an emphasis on continuous improvement and a focus on data integrity. This role will serve as business representative for laboratory IT systems and will be responsible for mentoring and educating peers on the use of laboratory systems and equipment, oversight for management reviews, laboratory metrics and laboratory documentation as well as supporting internal and external audits as a laboratory IT system subject matter expert.
Requirements
- Bachelor’s degree in a computer science, life science, or applied science or other relevant field.
- IT systems experience (installation and qualification of laboratory IT systems, population of master data, and configuration of systems).
- Experience in a GMP laboratory.
- Minimum 3 years of demonstrated relevant experience.
Nice To Haves
- Master’s degree in a computer science, life science, or applied science or other relevant field.
- Proficiency with computer systems including Microsoft Office products, LIMS, Laboratory Execution Systems, chromatography systems, electronic laboratory notebook systems including implementation of systems.
- Experience operating or implementing laboratory IT systems including LIMS and Automated Lab Execution systems.
- Investigation and deviation management experience.
- Demonstrated proficiency in computer system validation.
- Experience with compliance requirements and regulatory expectations.
- Excellent oral and written communication skills and demonstrated through documentation and presentation skills.
- Demonstrated accuracy and proficiency in analytical skills.
- Ability to work in a laboratory environment including wearing appropriate PPE and other safety related equipment or considerations.
- Previous experience with cross-function leadership utilizing problem-solving and decision-making skills.
Responsibilities
- Performs and/or supports the laboratory with the validation of laboratory equipment and software systems.
- Supports the establishment and maintenance of the validated state of software-based computerized systems in use within the laboratory.
- Leads and/or supports site deployment and upgrades of QC laboratory IT systems such as LabVantage LIMS, Empower, MODA, NuGenesis ELN and SDMS.
- Ensures data integrity by design within the QC laboratory.
- Acts as QC laboratory data integrity local representative.
- Partners and builds relationships with Global Quality Laboratory Network, Global and Site IT team members.
- Acts as a contact SME for QC laboratory IT systems.
- Performs non-terminal record monitoring activities.
- Supports audit trail discrepancies if found during system audit trail review.
- Supports continuous improvement of quality systems as they relate to the QC laboratory.
- Applies knowledge of quality principles, cGMP, and laboratory systems towards the development and execution of local procedures, training courses, and practices.
- Assists in improvement of quality systems by creating or revising worksheets, developing or updating laboratory execution system documentation, updating laboratory methods, and maintaining other laboratory documentation systems.
- Supports audit and inspection activities for the laboratory.
- Implements and complies with corporate, site, and laboratory safety standards.
Benefits
- company bonus
- company-sponsored 401(k)
- pension
- vacation benefits
- medical benefits
- dental benefits
- vision benefits
- prescription drug benefits
- flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- life insurance
- death benefits
- certain time off and leave of absence benefits
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
