Job Details

  • Title: Lab System Specialist
  • Code: RCI-32051/32052
  • Location: Devens Massachusetts (MA) 01434
  • Posted Date: 06/30/2020
  • Duration: 6 Months
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  Job Description

Principle Objective:

  • Support Quality Control data management systems primarily through use of Laboratory Information Management Systems (LIMS).
  • The focus of this role is in the Sample Manger LIMS (SMLIMS) sample builds and system maintenance, however, may require support of other data manage systems, such as LES or Empower.

Responsibilities:

  • Create/maintain/enhance user workflows within Quality Control data management systems as required to support routine testing activities, method transfers and validations and change control activities around these methods or systems.
  • Execute change management processes to document updates/changes to these systems.
  • Collaborate with end users to understand user needs and requests
  • Maintain processes/procedures to govern these systems.
  • Provide training and troubleshooting on relevant data management systems.
  • Communicate issues and technical failures to direct supervisor.
  • Attend project meetings and work closely with project manager, QA, and business team members to ensure project tasks are completed in a timely fashion.
  • Work with automation team regarding technical issues, upgrades and updates to systems as required.
  • Work with the global IT team, QC Operations and Microbiology teams.

Knowledge/Skills/Qualifications:

  • Knowledge of science generally attained through studies resulting in a B.S., in science, computer science engineering, biochemistry, a related discipline, or its equivalent is preferred.
  • Working knowledge of databases and laboratory applications including LIMS, Smartlab and Labware LIMS software desired.
  • Knowledge of analytical techniques, such as HPLC, spectroscopy, ELISA, Bioassay and GC methods, desired.
  • Knowledge of interfacing of the data management systems and impact to each other.
  • Good analytical and problem solving abilities.
  • Must be a team player with excellent communication and problem solving skills and have experience working with customers across teams.
  • Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices
  • Work in a cGMP laboratory and manufacturing environment following techniques which require one to maintain a high attention to detail, to properly use Personal Protective Equipment (PPE) and be in a laboratory environment that may contain hazardous materials.
  • May work on assignments that are extremely complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
  • Exercises judgment within broadly defined practices and policies in selecting methods and techniques and evaluation criteria for obtaining results.
  • Makes sound decisions and applies appropriate notification to management as appropriate.
  • Must have knowledge of computer software and operating systems including Windows XP, Windows Server 2000, Windows 2003 Server, Oracle, SQL Server