Fiscal Year

2021

Case Number

A-20189-73645

Case Status

Certified

Received Date

2020-07-07

Decision Date

2021-06-30

Refile

N

Original File Date

2021-01-01 09:44:12

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

Susie Shin

Agent Attorney Firm Name

Zulkie Partners LLC

Agent Attorney Phone

(312) 831-2127

Agent Attorney Address 1

135 South La Salle Street

Agent Attorney Address 2

Suite 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

sshin@zulkiepartners.com

PW Track Number

P10020016259276

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialist

PW Skill Level

Level IV

PW Wage

99736.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-04-15

PW Expiration Date

2020-07-14

Wage Offer From

100400.00

Wage Offer To

150600.00

Average Salary

125500.00

Wage Unit of Pay

Year

Worksite Address 1

500 Shire Way

Worksite Address 2

Worksite City

Lexington

Worksite City Slug

lexington

Worksite State

MASSACHUSETTS

Worksite Postal Code

2421

Job Title

GMP Clinical Senior QA Specialist II

Job Title Slug

gmp-clinical-senior-qa-specialist-ii

Minimum Education

Master's

Major Field of Study

Regulatory Affairs for Drugs, Biologics and Medical Devices, Chemistry, Biology, Pharmacy or related

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

9

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

84

Accept Alternative Job Title

Associate I Development Sciences or related

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

REQUIRED SKILLS PERFORM BATCH DOCUMENTATION REVIEW AND DISPOSITION ACTIVITIES PER CODE OF FEDERAL REGULATIONS CFR21 AND OTHER REGULATORY AGENCY REQUIREMENTS APPLICABLE 7 YEARS; WRITE, REVIEW, AND LEAD DEVIATION INVESTIGATIONS, CHANGE CONTROLS, CAPA, NONCONFORMANCE, OOS, COMPLAINTS AND RELATED TECHNICAL QUALITY SYSTEM DOCUMENTATION FOR COMPLIANCE TO REGULATORY REQUIREMENTS 7 YEARS; PROVIDE QUALITY AND COMPLIANCE SUPPORT FOR REGULATORY SUBMISSIONS AND REGULATORY AUDITS 7 YEARS; BUILD AND MAINTAIN STRONG WORKING RELATIONSHIPS WITH CMO, CTL, AND SUPPLIERS TO PROVIDE OVERSIGHT AND COMPLIANCE 7 YEARS; WORK WITH ASEPTIC BULK API VIAL DP FILLING AND WITH ASEPTIC VALIDATION PROCESSES AUTOCLAVE, DHS, SMOKE STUDY, MEDIA FILL PROCESS SIMULATION 7 YEARS; WORK AS ADMIN WITH ELECTRONIC DOCUMENT MANAGEMENT SYSTEMS EDMS AND ELMS SABA, ISO TRAIN, SUCCESSFACTORS, PLATEAU7 YEARS. Up to 10 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

2020-04-20

SWA Job Order End Date

2020-05-26

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2020-04-26

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-05-03

Employer Website From Date

2020-04-20

Employer Website To Date

2020-05-26

Professional Organization Ad From Date

2021-01-01 09:44:12

Professional Organization Advertisement To Date

2021-01-01 09:44:12

Job Search Website From Date

2020-04-26

Job Search Website To Date

2020-05-10

Employee Referral Program From Date

2020-03-23

Employee Referral Program To Date

2020-05-27

Local Ethnic Paper From Date

2021-01-01 09:44:12

Local Ethnic Paper To Date

2021-01-01 09:44:12

Radio/TV Ad From Date

2021-01-01 09:44:12

Radio/TV Ad To Date

2021-01-01 09:44:12

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 AND MEDICAL DEVICES

Foreign Worker Years of Education Completed

2015

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360HUNTINGTONAVENUE

Foreign Worker Education Institution Address 2

405ELLHALL

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

Susie Shin

Preparer Title

Principal

Preparer Email

sshin@zulkiepartners.com

Employer Information Declaration Name

Paul Lambert

Employer Information Declaration Title

Global Mobility Manager