Fiscal Year

2024

Case Number

A-23089-20852

Case Status

Certified

Received Date

2023-03-31

Decision Date

2024-04-22

Refile

N

Original File Date

2024-01-01 01:08:13

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

19608

Employer Year Commenced Business

1994

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Ken Brown

Employer Contact Address 1

300 Shire Way

Employer Contact Address 2

Employer Contact City

Lexington

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2421

Employer Contact Phone

6177942549

Employer Contact Email

ken.brown@takeda.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

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

sshin@zulkiepartners.com

PW Track Number

P10022160264115

PW SOC Code

13-1041.07

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level III

PW Wage

89024.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-12-22

PW Expiration Date

2023-06-30

Wage Offer From

102200.00

Wage Offer To

197100.00

Average Salary

149650.00

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

2142

Job Title

Senior Disposition Quality Specialist

Job Title Slug

senior-disposition-quality-specialist

Minimum Education

Bachelor's

Major Field of Study

Bachelor's degree in Pharmacy, Chemistry, or related field or foreign academic equivalent

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

36

Accept Alternative Job Title

Sr. Quality Assurance Specialist or related position.

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Required skills Perform review and disposition of APIDS, DP and FDP and support resolution of complex deviations, CAPA, Material Review Board, Market Action Investigation, nonconformance reviews and change controls; Lead as a system administrator in Veeva Vault Quality Docs and QMS, use of electronic document management system eDMS for regulatory filings and Enterprise Resource Planning ERP as SAP; Review regulatory filings and support the team in annual regulatory submissions APQRs. Participate in CMOCTL audit, perform internal audits and support quality in Business Review Meetings; Review batch documentation, finished goods labels, in process and release data, certificates of analyses, certificate of conformance and technical reports. Up to 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

2023-01-13

SWA Job Order End Date

2023-02-14

Sunday Edition Newspaper

Y

First Newspaper Name

Boston Sunday Globe

First Advertisement Start Date

2023-01-15

Second Newspaper Ad Name

Boston Sunday Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2023-01-22

Employer Website From Date

2023-01-13

Employer Website To Date

2023-02-28

Professional Organization Ad From Date

2024-01-01 01:08:13

Professional Organization Advertisement To Date

2024-01-01 01:08:13

Job Search Website From Date

2023-01-16

Job Search Website To Date

2023-02-13

Employee Referral Program From Date

2024-01-01 01:08:13

Employee Referral Program To Date

2024-01-01 01:08:13

Local Ethnic Paper From Date

2023-02-02

Local Ethnic Paper To Date

2023-02-02

Radio/TV Ad From Date

2024-01-01 01:08:13

Radio/TV Ad To Date

2024-01-01 01:08:13

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

PHARMACY

Foreign Worker Years of Education Completed

2017

Foreign Worker Institution of Education

DR. BHANUBEN NANAVATI COLLEGE OF PHARMACY

Foreign Worker Education Institution Address 1

VIE PARLE WEST

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

MUMBAI

Foreign Worker Education Institution State/Province

MAHARASHTRA

Foreign Worker Education Institution Country

INDIA

Foreign Worker Education Institution Postal Code

400056

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

Ken Brown

Employer Information Declaration Title

Global Mobility Strategy Lead