Validation Specialist

Company: Net2Source
Location: Princeton
Posted on: May 26, 2023

Job Description:

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap - Right Talent - Right Time - Right Place - Right Price and acting as a Career Coach to our consultants.



Company: One of Our Clients





Job Description:

Position: Validation Specialist

Location: Princeton, NJ (50% Remote)

Duration: 06+ Months (Extendable)

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Pay Rate: $69.00/hr on W2.

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Must Have List:

--- 2+ years of experience in managing the projects as CSV specialist /lead

--- 2+ years of experience in testing , (script reviewing from a QA perspective in particular )

--- 2+ years of experience in authoring , reviewing various validation documentation such as (Val plan , Risk assessments etc.)

--- 2+ years with 21 CFR Part 11 experience.

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Highly Preferred:

--- Prior BMS experience

--- Prior ERP experience

--- PM skills highly preferred

--- Great oral and written skills

--- Organized and lead a lot of high visibility project preferred.

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Description:

2+ years' experience

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.

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Review validation deliverables for projects which are contracted to third party suppliers

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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.

Review computerized systems validation documents such as:

--- Requirements Specification

--- Design Specification

--- CSV Risk Assessment

--- Test Plans

--- Test Summary Reports

--- Data Migration Plan

--- Pre/Post Executed Test Scripts

--- Traceability Matrix

--- Release to Production Statements

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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

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.

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.

Equal Employment Opportunity Statement:

Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.

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Awards and Accolades: -

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• America's Most Honored Businesses (Top 10%)
  
• Awarded by USPAAC for Fastest Growing Business in the US
  
• 12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
  
• Fastest 50 by NJ Biz (2020, 2019, 2020)
  
• INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
  
• Top 100 by Dallas Business Journal (2020 and 2019)
  
• Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
  
• 2019 Spirit of Alliance Award by Agile1
  
• 2018 Best of the Best Platinum Award by Agile1
  
• 2018 TechServe Alliance Excellence Awards Winner
  
• 2017 Best of the Best Gold Award by Agile1(Act1 Group)
  
  Regards,
  
  Kenneth Solomon
  
  Delivery Lead (Pharma and LifeSciences)
  
  Net2Source Inc.
  
  Global HQ Address -270 Davidson Ave, Suite 704, Somerset, NJ 08873, USA
  
  Office: (201) 340-8700 x 606 -- Cell: (201) 299-3923 - Fax: (201) 221-8131- Email:

Keywords: Net2Source, Trenton , Validation Specialist, Other , Princeton, New Jersey