Fiscal Year

2022

Case Number

A-21274-53090

Case Status

Certified

Received Date

2021-11-23

Decision Date

2022-05-16

Refile

N

Original File Date

2022-01-01 11:28:11

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

INGENUS PHARMACEUTICALS, NJ, LLC

Employer Name Slug

ingenus-pharmaceuticals-nj-llc

Employer Address 1

140 NEW DUTCH LN

Employer Address 2

Employer City

FAIRFIELD

Employer City Slug

fairfield

Employer State

NEW JERSEY

Employer State Slug

new-jersey

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

7004

Employer Phone

973-830-3285

Employer Number of Employees

107

Employer Year Commenced Business

2010

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Tammy Michaud

Employer Contact Address 1

140 New Dutch Ln

Employer Contact Address 2

Employer Contact City

Fairfield

Employer Contact State/Province

NEW JERSEY

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

7004

Employer Contact Phone

973-830-3285

Employer Contact Email

tmichaud@ingenus.com

Agent Attorney Name

David H Nachman

Agent Attorney Firm Name

NPZ Law Group, P.C.

Agent Attorney Phone

2016700006

Agent Attorney Address 1

487 Goffle Road

Agent Attorney Address 2

Visaserve Plaza

Agent Attorney City

Ridgewood

Agent Attorney State/Province

NEW JERSEY

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

7450

Agent Attorney Email

david_nachman@visaserve.com

PW Track Number

P10021028040764

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

69139.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-06-14

PW Expiration Date

2021-09-12

Wage Offer From

73861.00

Wage Offer To

0.00

Average Salary

73861.00

Wage Unit of Pay

Year

Worksite Address 1

140 New Dutch Lane

Worksite Address 2

Worksite City

Fairfield

Worksite City Slug

fairfield

Worksite State

NEW JERSEY

Worksite Postal Code

7004

Job Title

QA Associate (Compliance and Regulatory Affairs)

Job Title Slug

qa-associate-compliance-and-regulatory-affairs

Minimum Education

Master's

Major Field of Study

Regulatory Affairs of Drugs, Biologics and Medical Devices

Required Training

N

Required Experience

Y

Required Experience Months

24

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Pharmaceutical Sciences

Accept Alternative Combination

N

Accept Alternative Combination Education

Accept Alternative Combination Education Years

Accept Foreign Education

Y

Accept Alternative Occupation

N

Accept Alternative Occupation Months

Accept Alternative Job Title

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

MASTER OF SCIENCE DEGREE IN REGULATORY AFFAIRS OF DRUGS, BIOLOGICS AND MEDICAL DEVICES OR PHARMACEUTICAL SCIENCES AND TWO 2 YEARS OFbr EXPERIENCE IN QUALITY ASSURANCE WITHIN A GENERIC PHARMACEUTICAL ENVIRONMENT. APPLICANT MUST HAVE HANDSON EXPERIENCE IN PREPARING ANDbr REVIEWING CMC AND LABELING FOR REGULATORY FILINGS AND OTHER REGULATORY SUBMISSIONS WITH USFDA. MUST HAVE DEMONSTRATE EXPERTISE INbr DEVELOPING AND REVIEWING SOPS, CAPA, CHANGE CONTROLS, DEVIATIONS, MASTER BATCH RECORD, LAB REPORTS AND RISK ANALYSIS DOCUMENTS WITHbr ACCURACY AND MAINTAINING COMPLIANCE WITH TITLE 21 CFR 211, CGMP REGULATIONS, FDA, CFR AND ICH GUIDELINES. MUST BE PROFICIENT IN APPLICABLECOMPUTER AND DATABASE APPLICATIONS INCLUDING MS WORD, MS EXCEL, PDF, ECTD SUBMISSIONS SOFTWARE, AND LABELING DESIGN SOFTWARE.

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

2021-07-16

SWA Job Order End Date

2021-08-18

Sunday Edition Newspaper

Y

First Newspaper Name

The Star Ledger

First Advertisement Start Date

2021-08-22

Second Newspaper Ad Name

The Star Ledger

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-08-29

Employer Website From Date

2022-01-01 11:28:11

Employer Website To Date

2022-01-01 11:28:11

Professional Organization Ad From Date

2022-01-01 11:28:11

Professional Organization Advertisement To Date

2022-01-01 11:28:11

Job Search Website From Date

2021-08-22

Job Search Website To Date

2021-09-05

Employee Referral Program From Date

2022-01-01 11:28:11

Employee Referral Program To Date

2022-01-01 11:28:11

Local Ethnic Paper From Date

2021-08-26

Local Ethnic Paper To Date

2021-08-26

Radio/TV Ad From Date

2021-08-27

Radio/TV Ad To Date

2021-08-27

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

Master's

Foreign Worker Information: Major

REGULATORY AFFAIRS FOR DRUGS, BIOLOGICS MEDICAL DEVICES

Foreign Worker Years of Education Completed

2013

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360 HUNTINGTON AVE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BOSTON

Foreign Worker Education Institution State/Province

MA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

2115

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

David H Nachman

Preparer Title

Managing Attorney

Preparer Email

david_nachman@visaserve.com

Employer Information Declaration Name

Tammy Michaud

Employer Information Declaration Title

Sr. Director, HR