Fiscal Year

2022

Case Number

A-21277-53498

Case Status

Certified

Received Date

2021-10-21

Decision Date

2022-04-28

Refile

N

Original File Date

2022-01-01 11:21:46

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

SHIRE HUMAN GENETIC THERAPIES SHGT INC

Employer Name Slug

shire-human-genetic-therapies-shgt-inc

Employer Address 1

300 SHIRE WAY

Employer Address 2

Employer City

LEXINGTON

Employer City Slug

lexington

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

2421

Employer Phone

781-482-0599

Employer Number of Employees

47495

Employer Year Commenced Business

1994

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Patty Chookhae-Kragh

Employer Contact Address 1

650 East Kendall Street

Employer Contact Address 2

Employer Contact City

Cambridge

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2142

Employer Contact Phone

617-588-8463

Employer Contact Email

patty.chookhae-kragh@shire.com

Agent Attorney Name

Jennifer A Hoskin

Agent Attorney Firm Name

Zulkie Partners LLC

Agent Attorney Phone

(312) 831-2132

Agent Attorney Address 1

135 S LaSalle Street

Agent Attorney Address 2

Ste. 3425

Agent Attorney City

Chicago

Agent Attorney State/Province

ILLINOIS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

60603

Agent Attorney Email

jhoskin@zulkiepartners.com

PW Track Number

P10020358977098

PW SOC Code

19-4099

PW SOC Title

Quality Control Analysts

PW Skill Level

Level IV

PW Wage

75421.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-06-24

PW Expiration Date

2021-09-22

Wage Offer From

137200.00

Wage Offer To

274400.00

Average Salary

205800.00

Wage Unit of Pay

Year

Worksite Address 1

4555 Hayden Avenue

Worksite Address 2

Worksite City

Lexington

Worksite City Slug

lexington

Worksite State

MASSACHUSETTS

Worksite Postal Code

2421

Job Title

QA Disposition Lead

Job Title Slug

qa-disposition-lead

Minimum Education

Bachelor's

Major Field of Study

PHARMACY, CHEMISTRY, OR RELATED FIELD

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

96

Accept Alternative Job Title

QA Manager or rltd pstn

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

REQUIRED SKILLS PERFORM REVIEW AND DISPOSITION OF APIDS, DP AND FDP; EXPERIENCE WITH BIOLOGICS AND COMBINATION PRODUCTS INCLUDING REVIEW OF ANALYTICAL, IN VIVO, IN VITRO AND MICROBIOLOGICAL TESTING FOR CELL BANK RELEASE; FINAL PRODUCT VISUAL INSPECTION; REVIEW OF BIOLOGICS LICENSE APPLICATION SUBMISSIONS; USE OF ENTERPRISE RESOURCE PLANNING ERP AND CONTINUOUS IMPROVEMENT INITIATIVES USING A LEAN TOOL LIKE DMAIC OR KAIZEN; RESOLUTION OF COMPLEX DEVIATIONS, CAPA, MATERIAL REVIEW BOARD, MARKET ACTION INVESTIGATION, NONCONFORMANCE REVIEWS AND CHANGE CONTROLS AND USE OF ELECTRONIC DOCUMENT MANAGEMENT SYSTEM EDMS; STATISTICAL ANALYSIS AND TRENDING TO EVALUATE STABILITY STUDIES, PPQ REPORTS, METHOD TRANSFER REPORTS AND APQRS AND REPORTING OF KPI METRICS; SUPPLIER QUALITY MANAGEMENT AUDIT CMOCTL, AUTHOR AND REVIEW QUALITY TECHNICAL AGREEMENT; REPRESENT QUALITY IN BUSINESS REVIEW MEETINGS. 30 TRAVEL REQUIRED.

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

2021-08-02

SWA Job Order End Date

2021-09-03

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2021-08-01

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-08-08

Employer Website From Date

2021-07-30

Employer Website To Date

2021-09-03

Professional Organization Ad From Date

2022-01-01 11:21:46

Professional Organization Advertisement To Date

2022-01-01 11:21:46

Job Search Website From Date

2021-08-01

Job Search Website To Date

2021-08-30

Employee Referral Program From Date

2022-01-01 11:21:46

Employee Referral Program To Date

2022-01-01 11:21:46

Local Ethnic Paper From Date

2021-08-05

Local Ethnic Paper To Date

2021-08-05

Radio/TV Ad From Date

2022-01-01 11:21:46

Radio/TV Ad To Date

2022-01-01 11:21:46

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

PHARMACEUTICAL SCIENCES

Foreign Worker Years of Education Completed

2009

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

300 HUNTINGTON AVENUE

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

Jennifer A Hoskin

Preparer Title

Associate

Preparer Email

jhoskin@zulkiepartners.com

Employer Information Declaration Name

Paul Lambert

Employer Information Declaration Title

Global Mobility Manager