Overview
On Site
Full Time
Skills
Configuration Management
Change Management
Content Management
Technical Drafting
Management
System Requirements
Writing
Laboratory Equipment
Data Integrity
Job Details
Responsibilities:
Requirements:
- CM is looking for candidates that have experience with laboratory equipment qualifications, writing life cycle documents, drafting deviations, and are familiar with part 11 and DIA.
- A big part of this role is knowing the DIA (Data Integrity Assessment part 11) Knowing how to write an IOQ and execute it.
- IF they can do that the CM thinks they can cross over to other areas and can use that in both fill/finish and lab equipment.
- Please understand that this is an on-the-floor job.
- They will be executing IOQs, drafting documents, working cross functionally with teams to execute the IOQs on the floor, writing and resolving deviations.
- For lab equipment they have an SIA (system impact assessment) where they assess if there is impact to product and quality.
- From there they deem it as direct impact, no impact, or indirect impact. From there they do a system requirement spec, which is what the end users require from the instrument so all of that gets laid out into a lifecycle document.
- If its computerized system, it also includes 21CFR part 11 document and all of those feed into their equipment qualification assessment.
Requirements:
- The vendor will then come in and do their IOQ from there and they Sandbox, work on lifecycle documents, and the IOQ is drafted and routed for approval and then you go out and execute and resolve and deviations that may accrue.
- Candidates will also be supporting the fill/finish facility so any experience with fill/finish is going to be a big plus.
- Candidates will be writing and executing protocols and creating and executing life cycle documents.
- Candidates will need to be onsite and will be on the floor executing IOQ on lab equipment.
- Ideal candidates will have diverse experience with lab equipment validation and strong understanding of data integrity in laboratory.
- Knowledge of 21 CFR Part 11 and DIA (Data Integrity Assessments) is a strong plus.
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