(Archived) Quality Systems Specialist

Position Summary

This position is responsible for maintenance of the Laboratory Information Management System (LIMS) for Lincoln Operations (Lincoln, NE and Whitehall, IL) in support of Quality and Manufacturing. The LIMs system contains critical product, testing and release master data and is required to be maintained in a controlled and validated state. Responsibilities of this position include writing SAP/LIMS basic and complex code to support production and testing needs maintaining a controlled and validated state. to ensure it is in alignment with business needs, functions for the users, in a state of control, and in compliance with regulations and local and global procedures.

Position Responsibilities

• Independently write SAP/LIMS Basic code and complex subroutines in alignment with registered biological and analytical methods as well as product registered specifications globally
• Identify, develop, troubleshoot and implement LIMS initiatives globally and/or locally, as directed
• Identify opportunities and implement improvements to optimize configuration and system performance
• Build reports and queries in SAP/LIMS to extract data for analysis and reporting
• Trouble shoot and resolve issues arising in SAP/LIMS and its integration with other applications
• Represent the LIMs system during internal audits and regulatory inspections

Education and Experience

Minimum

• Minimum of 5 years’ experience with biological or analytical testing methods
• Experience writing LIMS Basic Code and writing and understanding complex subroutines
• Knowledge of USDA, EU and FDA requirements of a biological and pharmaceutical manufacturing facility

Preferred

• Bachelors with three - four years' experience, Masters with two years, or equivalent experience in biological or pharmaceutical sciences, engineering, computer or related discipline.
• A minimum of five years’ progressive experience with LIMs, including experience in LIMS administration and visual basic

Technical Skills and Competencies

Minimum Qualifications:

• Understanding of the Biological and Pharmaceutical manufacturing and release processes
• General understanding and grasp of LIMs master data
• Demonstrated ability to understand, manipulate and repair code
• Experience and comfort working with mathematical equations
• Problem solving skill to understand up and downstream impacts of system changes both in the LIMs system and the company holistically.
• Excellent interpersonal and communication skills (written and oral) required to interface across departments, sites and management levels.
• Proven ability to operate in an independent manner and manage multiple projects at one time
• Ability to make critical decisions related to system changes and testing required qualifying those changes.
• Strong Technical knowledge of Laboratory Information Management System and high level of understanding of how the SAP modules are linked and function
• Familiarity of biological (Reed Munch, ELISA, Sterility, etc.…) and pharmaceutical (HPLC, GC, LOD, TCU, etc.…) test methods
• Proficiency in English

Physical Position Requirements

• None