Fiscal Year

2021

Case Number

A-20210-81970

Case Status

Certified-Expired

Received Date

2020-08-05

Decision Date

2021-03-18

Refile

N

Original File Date

2021-01-01 09:07:21

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

ITI, Inc.

Employer Name Slug

iti-inc

Employer Address 1

430 East 29th St

Employer Address 2

Suite 900

Employer City

New York

Employer City Slug

new-york

Employer State

NEW YORK

Employer State Slug

new-york

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

10016

Employer Phone

(646) 440-9333

Employer Number of Employees

370

Employer Year Commenced Business

2001

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Regina Donohue

Employer Contact Address 1

430 East 29th St

Employer Contact Address 2

Suite 900

Employer Contact City

New York

Employer Contact State/Province

NEW YORK

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

10016

Employer Contact Phone

(646) 440-9333

Employer Contact Email

rdonohue@itci-inc.com

Agent Attorney Name

John F Quill

Agent Attorney Firm Name

Mintz Levin

Agent Attorney Phone

617-348-4401

Agent Attorney Address 1

One Financial Center

Agent Attorney Address 2

Agent Attorney City

Boston

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2111

Agent Attorney Email

jfquill@mintz.com

PW Track Number

P10020104481607

PW SOC Code

13-1041

PW SOC Title

Compliance Officers

PW Skill Level

Level IV

PW Wage

102752.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-07-27

PW Expiration Date

2021-06-30

Wage Offer From

168100.00

Wage Offer To

0.00

Average Salary

168100.00

Wage Unit of Pay

Year

Worksite Address 1

430 East 29th Street

Worksite Address 2

Suite 900

Worksite City

New York

Worksite City Slug

new-york

Worksite State

NEW YORK

Worksite Postal Code

10016

Job Title

Director, Clinical Quality Assurance

Job Title Slug

director-clinical-quality-assurance

Minimum Education

Bachelor's

Major Field of Study

Microbiology

Required Training

N

Required Experience

Y

Required Experience Months

72

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Biological Science, or a closely related academic field

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

72

Accept Alternative Job Title

Performing clinical quality assurance in the biotechpharmaceutical industry or research organizatio

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Bachelors degree, or foreign equivalent, in Microbiology, Biological Science, or a closely related academic field, plus six years of experience performing clinical quality assurance in the biotechpharmaceutical industry or research organizations. Experience, which may be gained concurrently, to include each of the followingbr 6 years of experience working with and interpreting FDAEU and ICH GCP regulations and guidelines;br 6 years of experience with regulatory authority inspections including FDA and EMA andor Certifications body;br 6 years of experience utilizing Quality Management System procedures, and utilizing IT systems supporting clinical and safety systems in compliance with 21 CFR part 11, Annex 11;br 6 years of experience working with external third parties to effectively execute the audit and inspection readiness strategy and approach;br 6 years of experience with computerized systems and compliance requirements for onpremises andor hosted environments;br 6 years of experience in reviewing, implementing and managing CAPA corrective and preventive action, change requests and deviations;br 3 years of experience auditing CROs, Central Laboratories, Institutional Review Boards and other service providers or suppliers providing services; andbr 3 years of experience working with ISO certifications for organizations, and performing privacy shieldGDPR compliance implementation.br br Position requires domestic and international travel approx. 1015.

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

2020-05-19

SWA Job Order End Date

2020-06-22

Sunday Edition Newspaper

Y

First Newspaper Name

New York Times

First Advertisement Start Date

2020-05-31

Second Newspaper Ad Name

New York Times

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-06-07

Employer Website From Date

2020-05-22

Employer Website To Date

2020-06-22

Professional Organization Ad From Date

2021-01-01 09:07:21

Professional Organization Advertisement To Date

2021-01-01 09:07:21

Job Search Website From Date

2020-05-31

Job Search Website To Date

2020-06-14

Employee Referral Program From Date

2021-01-01 09:07:21

Employee Referral Program To Date

2021-01-01 09:07:21

Local Ethnic Paper From Date

2020-06-02

Local Ethnic Paper To Date

2020-06-02

Radio/TV Ad From Date

2021-01-01 09:07:21

Radio/TV Ad To Date

2021-01-01 09:07:21

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

MICROBIOLOGY

Foreign Worker Years of Education Completed

2005

Foreign Worker Institution of Education

GUJARAT UNIVERSITY

Foreign Worker Education Institution Address 1

NAVRANGPURA

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

AHMEDABAD

Foreign Worker Education Institution State/Province

GUJARAT

Foreign Worker Education Institution Country

INDIA

Foreign Worker Education Institution Postal Code

380009

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

John F Quill

Preparer Title

Attorney

Preparer Email

jfquill@mintz.com

Employer Information Declaration Name

Regina Donahue

Employer Information Declaration Title

Vice President, Human Resources