CSV Validation Specialist (expert within GXP Lab settings)

FULLY REMOTE (EST CANDIDATES ONLY) - CSV Specialist and/or Senior CSV Specialist within GXP lab settings. Fully Remote 6 month Contract Position w/ options to extend or consider CtH

This Jobot Consulting Job is hosted by: Brett Walker
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Salary: $55 - $75 per hour

A bit about us:

A leading Lab system looking for a strong Computer Systems Validation Specialist within a Lab or adjacent setting.

Contract position (to start), likely a 6 month contract. Prefer NE but would entertain Central time zone candidates with the right experience.

Why join us?

Work with a leading Lab company at the forefront of CSV
Remote role!
Work with an experienced team that's looking for a strong leader who provides proven Change Management and Validation experience. Expert-level Director/Program Management experience within CSV GxP settings or adjacent environments.

Job Details

The CSV (Computer Systems Validation) Specialist or Sr. CSV Specialist is a member of our IT team responsible for the validation of systems across our technology environment. This position includes validation planning and execution for new projects, as well as upgrades and patches to existing systems. The CSV Specialist/Sr. CSV Specialist provides services to internal stakeholders as well as to regulated customers who use our services and have clinical, laboratory, or other regulated data within our systems.

Key Responsibilities:
Follow established SDLC (System Development Life Cycle) and Change Control procedures.
Assess the intended use of new applications, interfaces, and embedded instrument software for GxP and 21 CFR Part 11 requirements.
Participate in vendor assessments for adherence to applicable standards and guidelines, including ISO 9001/13485, ISO 27001, and GAMP 5.
Ensure that applicable 21 CFR Part 11 features, including electronic signatures and audit trails, are enabled in relevant applications for the accurate handling of GxP records.
Serve as a subject matter expert for internal stakeholders regarding GxP and CSV requirements.
Create and execute Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and regression testing, leveraging vendor processes and documentation where appropriate.
Perform periodic compliance reviews for systems.
Work with IT and laboratory stakeholders to ensure regulatory requirements for software and instruments are appropriately addressed and tested.
Assist customers with IT questionnaires and site audits, where applicable.
Maintain knowledge of current regulatory guidance, industry standards, and best practices.
Perform other job duties as assigned.

Desired Attributes:
Strong analytical and problem-solving skills.
Ability to organize and prioritize multiple, overlapping tasks.
Strong customer service skills.
Strong oral and written communication skills.
Ability to take initiative with limited oversight and guidance.

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