LABORATORY/TECH SUPPORT ASSISTANT ELKTON, VA Onsite.
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
ALPHA'S REQUIREMENT #23-00227
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
