Quality Control Analyst II
Company: I code innovation
Location: Fort Worth
Posted on: November 27, 2022
The QC Systems Analyst role is a function of the Quality Control
unit responsible for administration of the Labvantage Medical
Device Laboratory Information Management System (MDLIMS). The
position is responsible for first line of support for system end
users. The role administrates system configuration, interfaced
systems, master data and user login accounts as well the associated
Administrates the LabVantage 8 application to maintain and enhance
the system configuration while maintaining the system's validated
state. Track, assess and disposition of enhancements, bug fixes and
general user questions.
Scheduling, testing and releasing master data for Analytical,
Incoming Inspection and Microbiology Labs.
Gather, analyze, document and validates business and user
requirements while maintaining system life cycle documents.
Provides operational support and data analysis/trending for LIMS
and other laboratory data systems.
Follows established change control procedures for SOP changes,
system technical changes and master data changes.
Provides support for laboratory computers and instruments.
Performs investigations, root cause analysis, correction/preventive
action plans. Develops training materials and delivers training to
system end users.
Minimum Required: LIMS and/or ELN experience with: QC related
instrument/application experience (preferably support experience)
Solid knowledge of quality control systems, FDA compliance,
standards, regulations, and guidelines. Understanding of HPLC,
UV-VIS, FTIR, and titration instruments. Excellent organizational
and teamwork skills. Excellent oral and technical writing skills.
Excellent level of written and spoken English required. Proficiency
in MS Word and MS Excel.
Preferred Level: Minimum requirements plus experience with
LabVantage application and database knowledge.
Bachelor of Science in Chemistry, Microbiology, or Computer Science
from an accredited university.
Minimum Required: 3 years of relevant experience in a cGMP
regulated environment. Preferred Level: 5+years of relevant
experience in a cGMP regulated environment with knowledge of FDA
and Quality System requirements
Job Type: Contract
Salary: $30.00 - $35.00 per hour
* 8 hour shift
Ability to commute/relocate:
* Fort Worth, TX 75028: Reliably commute or planning to relocate
before starting work (Required)
* Quality control: 1 year (Required)
* Quality inspection: 1 year (Required)
* Laboratory information management systems: 1 year (Required)
* HPLC: 1 year (Required)
* FDA regulations: 1 year (Required)
* Day Shift (Required)
Work Location: One location%58047475%
Keywords: I code innovation, Fort Worth , Quality Control Analyst II, Professions , Fort Worth, Texas
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