QC Information Services Analyst (GMP, Empower, ELN System, LAB, IT Support)

Overview

On Site
$DOE
Contract - W2
Contract - 11 month(s)

Skills

Performance Management
Project Management
Preventive Maintenance
Business Analytics
Business Analysis
Scripting
Software Configuration
Identity Management
Analytical Skill
Software Administration
Manufacturing
Documentation
Assays
Data Management
Management
GMP
GxP
Computerized System Validation
Writing
Test Scripts
Standard Operating Procedure
System Documentation
ELN
Quality Control
Technical Support
LIMS
LES
Veeva
Information Systems
Biotechnology
Information Management

Job Details

Job title: Senior QC Information Services Analyst (GMP, LIMS, IT Support)
Location: Fredrick, MD - 100% onsite
Working Hours- M-F 8am-4pm or 9am-5pm
Manager Notes:
ELN System (Electronic Lab Notebook)
Empower configuration
Lab experience
Lab exucution system
Computer system validation
BA degree preferred
Not completely looking for IT role or Lab role, this is way in the middle
Looking for some one in Biologics or pharmacitical background


Typical day will include project work, password resets, user access requests, software troubling shooting, make restricted folders for users, writing SOPs, executing text scripts.

Manager is looking for Software IT experience including software configuration and user management.

As a QC Information Systems (QCIS) Specialist, you will act as an administrator of computerized systems and business analyst between labs groups and IT for Enterprise projects such as Empower, Biovia Laboratory Execution Systems (LES), Labware, LIMS, and other digital initiatives.
Candidates should have a technical understanding of GMP analytical laboratory Information and Enterprise systems.
Responsible for day-to-day job functions, administration tasks and can independently represent the team for site and global initiatives.

Perform day-to-day activities and application administration of lab and manufacturing quality control computerized systems.
Support QC lab functions, providing solutions to a variety of technical problems.
Ability to interpret scientific documentation (quality assay SOPs, Master Specifications, etc.) in order to translate information into static data configuration and reports in LIMS, Empower, and other computerized data management systems.

skills Required
experience managing user access, resetting passwords, and administering folder permissions in a regulated lab or IT environment
experience working in a GMP or GxP-regulated environment
familiar with Computer System Validation (CSV) processes, including writing or executing test scripts or validation protocols
contributed to Standard Operating Procedures (SOPs) or system documentation
experience, do you have supporting lab or QC information systems
experience you have with static data configuration in LIMS, Empower, ELN System (Electronic Lab Notebook) and other QC systems.
lab systems support with. Empower (Waters CDS), LabWare LIMS, Biovia LES, Veeva Vault

Education:
Bachelor's Degree preferably in Information Systems/Technology or Biotechnology related field.
0-3+ years information management experience is preferred.
Experience in a scientific lab setting is a plus.
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