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Quality Control Analyst II

Company: I code innovation
Location: Fort Worth
Posted on: November 27, 2022

Job Description:

Duties
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 laboratory instrumentation.

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.

Skills
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.

Education
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

Schedule:
* 8 hour shift

Ability to commute/relocate:
* Fort Worth, TX 75028: Reliably commute or planning to relocate before starting work (Required)

Experience:
* 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)

Shift availability:
* 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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