Fiscal Year

2021

Case Number

A-20231-89377

Case Status

Certified

Received Date

2020-10-26

Decision Date

2021-05-04

Refile

N

Original File Date

2021-01-01 09:19:30

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

ERNST YOUNG U.S. LLP

Employer Name Slug

ernst-young-us-llp

Employer Address 1

200 PLAZA DRIVE

Employer Address 2

Employer City

SECAUCUS

Employer City Slug

secaucus

Employer State

NEW JERSEY

Employer State Slug

new-jersey

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

7094

Employer Phone

201-872-2200

Employer Number of Employees

40000

Employer Year Commenced Business

1989

NAICS Code

541211

FW Ownership Interest

N

Employer Contact Name

Sunday D Rubenstein

Employer Contact Address 1

200 Plaza Drive

Employer Contact Address 2

Employer Contact City

Secaucus

Employer Contact State/Province

NEW JERSEY

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

7094

Employer Contact Phone

201-872-2200 2899

Employer Contact Email

Sunday.Rubenstein@ey.com

Agent Attorney Name

Joo Young Seo

Agent Attorney Firm Name

EY Law LLP

Agent Attorney Phone

416 943 3548

Agent Attorney Address 1

100 Adelaide Street West

Agent Attorney Address 2

Floor 31

Agent Attorney City

Toronto

Agent Attorney State/Province

Ontario

Agent Attorney Country

CANADA

Agent Attorney Postal Code

M5H 0B3

Agent Attorney Email

eyusperm@ca.ey.com

PW Track Number

P10019317144667

PW SOC Code

13-1111

PW SOC Title

Management Analysts

PW Skill Level

Level IV

PW Wage

143437.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-03-06

PW Expiration Date

2020-06-30

Wage Offer From

143437.00

Wage Offer To

0.00

Average Salary

143437.00

Wage Unit of Pay

Year

Worksite Address 1

99 Wood Avenue South

Worksite Address 2

Worksite City

Iselin

Worksite City Slug

iselin

Worksite State

NEW JERSEY

Worksite Postal Code

8830

Job Title

Risk Advisor, RCTS (Life Sciences Quality & Compliance) (Manager)

Job Title Slug

risk-advisor-rcts-life-sciences-quality-compliance-manager

Minimum Education

Bachelor's

Major Field of Study

Pharmacy

Required Training

N

Required Experience

Y

Required Experience Months

60

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Biotechnology, Bioengg, Med. Tech, Biology, Chem, Engg, Business or related

Accept Alternative Combination

Y

Accept Alternative Combination Education

Master's

Accept Alternative Combination Education Years

4

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

60

Accept Alternative Job Title

Any in which the required experience is gained.

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Must have a Bachelors degree in Pharmacy, Biotechnology, Bioengineering, Medical Technology, Biology, Chemistry, Engineering, Business or a related field and 5 years of progressive, postbaccalaureate related work experience. Alternatively, will accept a Masters degree in Pharmacy, Biotechnology, Bioengineering, Medical Technology, Biology, Chemistry, Engineering, Business or a related field and 4 years of related work experiencebr br Must have 4 years of experience in delivering advisory or consulting services to Life Sciences clients, or in compliance within the Life Sciences industrybr br Must have 3 years of quality management system QMS experience working with applicable regulatory requirements including 21 CFR Parts 11, 210, 211, 610, and 820, or HIPAAbr br Must have 3 years of experience in project management, including accountability for schedules, deliverables, priorities and dependencies, progress updates, team management, and client servicebr br Must have 2 years of experience in one or more of the followingbr br Quality and regulatory operations, developing, improving or remediating Quality management systems for Life Sciences organizations, performing or managing responses to health authority e.g. FDA observations, and implementing LIMS and other QMS systemsbr Developing cGxP audit plans, assessments and reports. Assessing, designing and implementing audit, risk management or compliance programs including risk governance, risk appetite and tolerance, riskbased strategicbusiness planning processes, and integration of risk management functionsbr Designing continuous process improvement frameworks, tools and templates, conducting root cause assessment, and defining corrective and preventative actions CAPA in GxP environmentbr Computerized System Validation CSV and testing in a validated environment, with handson experience with SDLC requirements, Agile or Waterfall methodologies, testing automation Quality Center or ValGenesis, and tracking issues using JIRAbr Endtoend management of clinical trials including study design; study coordination; patient data acquisition and management; close out; external data management; regulatory reporting; and riskbased monitoringbr br Requires travel up to 80, to serve client needsbr br Employer will accept any suitable combination of education, training or experience.

Combination Occupation

N

Offered to Applicant Foreign Worker

Y

Foreign Worker Live on Premises

N

Foreign Worker Live in Domestic Service

N

Foreign Worker Live in Domestic Service Count

Professional Occupation

Y

Application for College/University Teacher

N

SWA Job Order Start Date

2020-06-22

SWA Job Order End Date

2020-07-27

Sunday Edition Newspaper

Y

First Newspaper Name

The StarLedger

First Advertisement Start Date

2020-06-28

Second Newspaper Ad Name

The StarLedger

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-07-05

Employer Website From Date

2020-06-22

Employer Website To Date

2020-07-27

Professional Organization Ad From Date

2021-01-01 09:19:30

Professional Organization Advertisement To Date

2021-01-01 09:19:30

Job Search Website From Date

2020-06-23

Job Search Website To Date

2020-07-27

Employee Referral Program From Date

2020-06-22

Employee Referral Program To Date

2020-07-27

Local Ethnic Paper From Date

2021-01-01 09:19:30

Local Ethnic Paper To Date

2021-01-01 09:19:30

Radio/TV Ad From Date

2021-01-01 09:19:30

Radio/TV Ad To Date

2021-01-01 09:19:30

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

INDIA

Foreign Worker Birth Country

INDIA

Class of Admission

H-1B

Foreign Worker Education

Bachelor's

Foreign Worker Information: Major

PHARMACEUTICAL SCIENCE RELATED TO PHARMACY

Foreign Worker Years of Education Completed

2009

Foreign Worker Institution of Education

JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Foreign Worker Education Institution Address 1

ASHOK NAGAR, KUKATPALLY HOUSING BOARD COLONY, KUKATPALLY

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

HYDERABAD

Foreign Worker Education Institution State/Province

TELANGANA

Foreign Worker Education Institution Country

INDIA

Foreign Worker Education Institution Postal Code

500085

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Joo Young Seo

Preparer Title

Attorney

Preparer Email

eyusperm@ca.ey.com

Employer Information Declaration Name

Renet Shakeria FAGAN COLLIECHARLTON

Employer Information Declaration Title

Supervising AssociateAssociate Director, ATT