Fiscal Year

2022

Case Number

A-21141-90128

Case Status

Certified-Expired

Received Date

2021-06-25

Decision Date

2021-12-01

Refile

N

Original File Date

2022-01-01 10:31:08

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

49578

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

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

P10020150612178

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level IV

PW Wage

164694.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-11-03

PW Expiration Date

2021-06-30

Wage Offer From

165000.00

Wage Offer To

195800.00

Average Salary

180400.00

Wage Unit of Pay

Year

Worksite Address 1

125 Spring Street

Worksite Address 2

Worksite City

Lexington

Worksite City Slug

lexington

Worksite State

MASSACHUSETTS

Worksite Postal Code

2421

Job Title

Sr QA Specialist

Job Title Slug

sr-qa-specialist

Minimum Education

Master's

Major Field of Study

REGULATORY AFFAIRS 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

60

Accept Alternative Job Title

QA Specialist or rltd pstn

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

WILL ACCEPT ANY LEVEL OF EXPERIENCE IN THE FOLLOWING SKILLS EXPERIENCE WITH BATCH RELEASE PROCESS AND EXCURSIONS GENERATED DURING GMP ACTIVITIES SUCH AS DEVIATIONS, NONCONFORMANCES NCR, OUT OF SPECIFICATION OOS INVESTIGATIONS AND CAPA; DIRECT EXPERIENCE IN PREPARING AND REVIEWING MATERIALS FOR DEVICE SUBMISSIONS TO REGULATORY AUTHORITIES I.E. FDA, EUROPEAN BODIES; EXPERIENCE IN LEADING, CONDUCTING, HOSTING MEDICAL DEVICE QUALITY SYSTEM AUDITS PER ISO 13485 AND 21 CFR 820 IN ADDITION TO MEDICAL DEVICE RISK ASSESSMENT PER ISO 14971 AND ASSOCIATED TOOLS FMEA, FMECA; WORKING KNOWLEDGE OF E.U., U.S. AND INTERNATIONAL DRUGS AND MEDICAL DEVICE REGULATIONS AND STANDARDS INCLUDING FDA 21 CODE OF FEDERAL REGULATIONS CFRS PART 820, 803, 211, 210, E.U. IVD AND MEDICAL DEVICE REGULATIONS, ISO 13485, ISO 14971.

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

2021-03-15

SWA Job Order End Date

2021-04-16

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2021-03-14

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-03-21

Employer Website From Date

2021-03-12

Employer Website To Date

2021-04-20

Professional Organization Ad From Date

2022-01-01 10:31:08

Professional Organization Advertisement To Date

2022-01-01 10:31:08

Job Search Website From Date

2021-03-14

Job Search Website To Date

2021-04-12

Employee Referral Program From Date

2022-01-01 10:31:08

Employee Referral Program To Date

2022-01-01 10:31:08

Local Ethnic Paper From Date

2021-03-18

Local Ethnic Paper To Date

2021-03-18

Radio/TV Ad From Date

2022-01-01 10:31:08

Radio/TV Ad To Date

2022-01-01 10:31:08

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

2015

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360 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