TrentonRecruiter Since 2001
the smart solution for Trenton jobs

Computer Systems Validation Specialist - Mid-level

Company: Alpha Consulting Corp.
Location: Trenton
Posted on: November 22, 2020

Job Description:

COMPUTER SYSTEMS VALIDATION SPECIALIST MID LEVEL PRINCETON, NJ Required Skills Must Haves 6 years of CSV experience 6 years of MS Office Suite and Visio 3 years of HP ALMJIRA 3 years of ServiceNow and SAP 3 years of experience with 21 CFR Part 11 Skills 6 years' experience 0-2 yrs Some prior experience with Argus and ArisGlobal is desirable. Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project. Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.) application development and lifecycle management (e.g. HP ALM, JIRA, etc.) and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc). Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members. Once trained, have the ability to work independently on CSV projects with minimal oversight. Ability to perform in a highly matrixed organization structure. Ability to create documents to an existing document standard. Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries. Project Description Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes. Follow SOPs and industry best practices. Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar. Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system. Review validation deliverables for projects which are contracted to third party suppliers. Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues. Assist in planning, implementing, and documenting user acceptance testing. Review computerized systems validation documents such as Requirements Specification Design Specification CSV Risk Assessment Test Plans Test Summary Reports Data Migration Plan PrePost Executed Test Scripts Traceability Matrix Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data or the system. Obtain and respond to QA review. Participate in establishing standard quality and validation practices. Independently assess compliance practices and recommend corrective actions. Approve validated computer system related change requests. Monitor regulatory and inspection trends and advise the business on suitable action. This 6 month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Cheryl mailto ALPHA'S REQUIREMENT 20-01940 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE ZR

Keywords: Alpha Consulting Corp., Trenton , Computer Systems Validation Specialist - Mid-level, Other , Trenton, New Jersey

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Order Picker
Description: Shift: Sunrise/Preload 4:30 AM - 9:00 AM --WAREHOUSE WORKER PACKAGE HANDLERFind out what you ll become as a Package Handler at UPS. In this fast-paced
Company: United Parcel Service
Location: Westport
Posted on: 11/29/2020

Part-Time Delivery - Uber Eats
Description: Part-Time Delivery - Uber Eats Levittown, PA 2854 C2-11591 Deliver with Uber. Earn on your schedule. Work on your schedule. Deliver for a few hours in the mornings, every night, or just on weekends (more...)
Company: Uber Eats
Location: Levittown
Posted on: 11/29/2020

CDL Driver
Description: UPS is hiring individuals to work as full-time, temporary, seasonal Tractor-Trailer Drivers . This position involves driving a tractor-trailer unit to one or more destinations and then returning to the (more...)
Company: United Parcel Service
Location: Levittown
Posted on: 11/29/2020


Flexible Schedule - Deliver with Uber Eats
Description: Flexible Schedule - Deliver with Uber Eats Levittown, PA 2854 C2-655083 Deliver with Uber. Earn on your schedule. Work on your schedule. Deliver for a few hours in the mornings, every night, or just on (more...)
Company: Uber Eats
Location: Levittown
Posted on: 11/29/2020

Harrisburg West Seasonal Position
Description: The temporary part-time supervisor impacts the organization by administering and communicating UPS policies, procedures and programs in several of the following areas: employment, employee communication, (more...)
Company: United Parcel Service
Location: Levittown
Posted on: 11/29/2020

cdl a truck driver
Description: UPS is hiring individuals to work as full-time, temporary, seasonal Tractor-Trailer Drivers . This position involves driving a tractor-trailer unit to one or more destinations and then returning to the (more...)
Company: United Parcel Service
Location: Levittown
Posted on: 11/29/2020

Order Picker
Description: Shift: Sunrise/Preload 4:30 AM - 9:00 AM WAREHOUSE WORKER PACKAGE HANDLER Find out what youll become as a Package Handler at UPS. In
Company: United Parcel Service
Location: Westport
Posted on: 11/29/2020

Warehouse Team Member
Description: Shift: Sunrise/Preload 4:30 AM - 9:00 AM WAREHOUSE WORKER PACKAGE HANDLER Find out what youll become as a Package Handler at UPS. In
Company: United Parcel Service
Location: Westport
Posted on: 11/29/2020

Seasonal Retail Commission Sales - Women's Shoes Sales Associate, Part Time: Oxford Valley
Description: Overview: The Seasonal Women's Shoes Associate is responsible for providing outstanding customer service, and demonstrating superior product knowledge to customers during periods of high volume. To create (more...)
Company: Macy's
Location: Levittown
Posted on: 11/29/2020

Set Your Own Schedule - Shop and Deliver Groceries
Description: Shipt is a membership-based marketplace that helps people get the things they need, like fresh produce and household essentials, from stores they trust. Help people save time and have fun while you're (more...)
Company: Shipt
Location: Levittown
Posted on: 11/29/2020

Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

Trenton RSS job feeds