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Laboratory/Tech Support Assistant

Elkton, VA

Posted: 01/27/2023 Job Number: 22973277

Job Description


Required Skills:
  • A minimum of 3-5 years (Associate degree) and 1-3 years (BS) with relevant experience within GMP DATA/REGULATED ENVIRONMENT.
  • Candidate should be familiar with clean room/aseptic environments.
  • Working knowledge of windows computers.
  • Ability to navigate menu options in equipment with embedded electronic controls.
  • Ability to self-organize tasks to meet deadlines.
  • Ability to strictly follow procedures exactly as written.
  • Candidate should be familiar with clean room/aseptic environments.
  • Applied professional work experience in one of the following three areas:
  • GMP regulated area such as pharmaceutical laboratory, manufacturing, or technical support.
  • Laboratory or computer-controlled instrumentation.
  • Computer systems with controls for a regulated industry.
  • Administration of LIMS, database, and/or laboratory instrumentation.
  • Strong working knowledge of laboratory, manufacturing and support systems, and associated business processes.
  • Familiarity with System Development Life Cycle methodologies.
  • Knowledge of GDPs and regulatory requirements for pharmaceuticals.
  • Individuals with the following experience are strong candidates:
    • Secure Desktop (Visual Automation product or similar shell product to produce 'kiosk' type mode).
    • Windows OS settings/configuration with regards to file/folder security settings (access)
    • Windows OS policies.
    • Use of Computerized Laboratory instruments such as Particle counters (non-computerized as well), computer administration work is also a plus.
    • SDLC experience (computer validation), SharePoint, Office suite, 0-3 years of experience in skillset.
  • Personality:
    • Self-directed, organized, and proficient worker with a strong work ethic!
    • Independent, team player, focused.

Project Description:
  • Backup data from portable equipment used in aseptic areas.
    • Enter aseptic laboratories and/or production area (*must not be sensitive to beta-lactam antibiotics).
    • Reconcile supply of portable equipment (vs. Inventory list).
    • Plug equipment into computer systems and initiate backup per procedure/SOP.
    • Confirm backup completion.
    • Document actions and completions.
  • Change configuration settings on portable equipment and document changes per standard operating procedure.
  • Creation and Removal of User accounts on the portable equipment units as per SOP.
  • Performance of Periodic time checks and DST/EST time adjustments on the portable equipment units as per SOP.
  • Execution of approved portable equipment unit qualification documentation.
  • Oversight of the portable equipment vendor during unit calibration activities.
  • Execute procedures for monitoring automated backup system.
  • Document actions per written procedure describing such.
  • Depending on the skillset of the successful candidate, assist in various tasks and projects involving laboratory instrumentation (computerized); this involves assisting senior level specialists with subtasks in any of the following items: implementation of new systems, changing or reconfiguring existing systems, monitoring of automated backups, evaluation of operation, maintenance of user accounts, revising SOPs.
  • Resource will attend a morning meeting with the extended team.
  • Resource would then separate and go to aseptic manufacturing area to work with technicians to gather instruments and transfer data.
  • In addition, resource would also complete data accountability and document activities per SOP.
  • Resource will also assist with scheduling & coordination of maintenance activities with area management.
  • In addition, resource would assist or own equipment re-qualification & configuration process, monitor other system backups and, depending on skillset, assist with laboratory automation.
  • Resource is responsible for entering lab/manufacturing areas to perform activities.
  • This is done alone and in a " heads down " manner, without collaboration.
  • Collaboration with team after lab projects are completed.

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Charelen: charelen@alphaconsulting.Com


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Jessica Junqua

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