Fiscal Year

2021

Case Number

A-20278-07121

Case Status

Certified

Received Date

2020-11-01

Decision Date

2021-05-20

Refile

N

Original File Date

2021-01-01 09:25:51

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

AMERICAN REGENT, INC.

Employer Name Slug

american-regent-inc

Employer Address 1

5 RAMSEY ROAD

Employer Address 2

Employer City

SHIRLEY

Employer City Slug

shirley

Employer State

NEW YORK

Employer State Slug

new-york

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

11967

Employer Phone

631-924-4000

Employer Number of Employees

1016

Employer Year Commenced Business

1978

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

RASMA RUSSO

Employer Contact Address 1

5 RAMSEY ROAD

Employer Contact Address 2

Employer Contact City

SHIRLEY

Employer Contact State/Province

NEW YORK

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

11967

Employer Contact Phone

631-924-4000

Employer Contact Email

rrusso@americanregent.com

Agent Attorney Name

Shintaro Araki

Agent Attorney Firm Name

Fragomen, Del Rey, Bernsen Loewy, LLP

Agent Attorney Phone

212-688-8555

Agent Attorney Address 1

1400 Broadway

Agent Attorney Address 2

Agent Attorney City

New York

Agent Attorney State/Province

NEW YORK

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

10018

Agent Attorney Email

saraki@fragomen.com

PW Track Number

P10020044322460

PW SOC Code

15-1121

PW SOC Title

Computer System Analysts

PW Skill Level

Level IV

PW Wage

113963.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-05-05

PW Expiration Date

2020-08-03

Wage Offer From

113963.00

Wage Offer To

0.00

Average Salary

113963.00

Wage Unit of Pay

Year

Worksite Address 1

6610 New Albany Road East

Worksite Address 2

Worksite City

New Albany

Worksite City Slug

new-albany

Worksite State

OHIO

Worksite Postal Code

43054

Job Title

GxP System Specialist Team Lead

Job Title Slug

gxp-system-specialist-team-lead

Minimum Education

Bachelor's

Major Field of Study

** Please see H.14. **

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

N

Accept Alternative Combination Education

Accept Alternative Combination Education Years

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

84

Accept Alternative Job Title

Please see H. 14.

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Minimum education required Bachelors degree in any field.br Minimum experience required 7 years of experience working with GxP computer systems in the pharmaceutical or similarly regulated industry; and 2 years of experience managing or supervising computer system specialist teams.br Skills required Demonstrated ability to describe working with software and technology infrastructure within a laboratory, clinical trial company, or a GMP manufacturing facility and discuss how regulations like 21 CFR Part 11, 210, 211 dictate the software creation, testing, and implementation for the systems used in these environments; Demonstrated ability to describe appropriate Quality Systems and current Good Manufacturing Practice cGMP requirements FDA, EU, ICH with the ability to assess compliance risks, such as speaking to guidance like GAMP 5 FDA or Annex 11 EU and discussing how massive documents break down the preferred way to manage software at a GMPregulated facility, including the ability to tie specific software requirement documents to specific types of software testing; Demonstrated ability to provide oversight in implementing and maintaining GxP computer systems in a validated state; Demonstrated ability to effectively discuss core principles of validation methodology and software development lifecycle SDLC, such as requirements gathering, test cases strategy, consistent development strategy, standard implementation process, support, updates, etc.; Demonstrated ability to resolve conflicts and disputes on regulatory compliance issues. Employer will accept any amount of professional experience with the required skills.br Requires ability to perform limited domestic and international travel to office and plant sites.

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

2020-07-29

SWA Job Order End Date

2020-09-11

Sunday Edition Newspaper

Y

First Newspaper Name

The Columbus Dispatch

First Advertisement Start Date

2020-08-02

Second Newspaper Ad Name

The Columbus Dispatch

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-08-09

Employer Website From Date

2020-07-30

Employer Website To Date

2020-08-14

Professional Organization Ad From Date

2021-01-01 09:25:51

Professional Organization Advertisement To Date

2021-01-01 09:25:51

Job Search Website From Date

2020-07-30

Job Search Website To Date

2020-08-14

Employee Referral Program From Date

2021-01-01 09:25:51

Employee Referral Program To Date

2021-01-01 09:25:51

Local Ethnic Paper From Date

2020-08-07

Local Ethnic Paper To Date

2020-08-07

Radio/TV Ad From Date

2021-01-01 09:25:51

Radio/TV Ad To Date

2021-01-01 09:25:51

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

ELECTRONICS AND INSTRUMENTATION ENGINEERING

Foreign Worker Years of Education Completed

2006

Foreign Worker Institution of Education

THE WEST BENGAL UNIVERSITY OF TECHNOLOGY

Foreign Worker Education Institution Address 1

BF BLOCK, SECTOR 1, BIDHANNAGAR

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

KOLKATA

Foreign Worker Education Institution State/Province

WEST BENGAL

Foreign Worker Education Institution Country

INDIA

Foreign Worker Education Institution Postal Code

700064

Foreign Worker Experience with Employer

N/A

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Shintaro Araki

Preparer Title

Partner

Preparer Email

saraki@fragomen.com

Employer Information Declaration Name

Johana Fina

Employer Information Declaration Title

Human Resources Executive Director