QC Specialist II - Laboratory Information Systems

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The QC Specialist II – Laboratory Information Systems will use their depth of experience in software, computerized systems, QC testing, and GMP manufacturing to maintain and/or help implement laboratory information systems.  Systems currently include MODA-EM/FDC and Empower.  Future systems will likely include LIMS and SAP B1. Collaborate with Quality Control Microbiology/Analytical/Sample Management and Manufacturing to determine how to use available systems to implement and/or improve upon existing business processes.

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Initially will consist of approximately 80% MODA-EM configuration, 20% Empower configuration, and other Laboratory workflow improvements as assigned (may include Excel and/or SmartSheets).  MODA-EM will ramp down over time to approximately 25%, and be replaced with LIMS and SAP B1
• Work with IT, QA, Validation, and other groups as needed to support implementation of LIMS, SAP B1, and other laboratory information systems.
• Maintain configuration of systems as needed based on changes to business practices or procedures.
• Lab Administrator or super user of laboratory information systems.
• Maintaining validation of systems per FDA regulations (CFR Part 11)
• Work with all levels of employees to support compliant and efficient deployment of laboratory information systems.
• Training and support for employees who use the laboratory information systems.

Special Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions

• Stationary Position: 3/4 of the day and up.
• Move, Traverse: Up to 1/4 of the day.
• Operate, activate, use, prepare, inspect, or place: None
• Install, place, adjust, apply, measure, use, or signal: None.
• Ascend/Descend or Work Atop: None.
• Position self (to) or Move (about or to): Up to 1/4 of the day.
• Communicate or exchange information: 3/4 of the day and up.
• Detect, distinguish, or determine: 3/4 of the day and up.

On an average day, the individual can expect to move and/or transport up to 10 pounds less than 1/4 of the day.

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Bachelor's Degree in Computer Sciences, Biological Sciences, or related discipline; or equivalent experience
• Minimum of one to two years of experience with maintaining laboratory information systems (such as MODA, LIMS, Empower, SAP B1) and/or in a laboratory setting requiring use of laboratory information system(s).
• Minimum of one to two years of experience in a cGMP environment.
• Basic Mathematical Skills
• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.             
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.

Preferred

• Ability to effectively present information to various people as the job requires.
• Ability to display excellent time management skills.
• Ability to display original thinking and creativity.
• Ability to work independently and/or part of a team.
• Basic laboratory information system administration and/or configuration experience.
• Able to effectively communicate technical concepts to some non-technical audiences
• Excellent problem-solving skills

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