Fiscal Year

2021

Case Number

A-21036-49365

Case Status

Certified

Received Date

2021-02-26

Decision Date

2021-07-23

Refile

N

Original File Date

2021-01-01 09:52:52

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Xellia Pharmaceuticals USA, LLC

Employer Name Slug

xellia-pharmaceuticals-usa-llc

Employer Address 1

200 Northfield Road

Employer Address 2

Employer City

Bedford

Employer City Slug

bedford

Employer State

OHIO

Employer State Slug

ohio

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

44146

Employer Phone

3129642487

Employer Number of Employees

349

Employer Year Commenced Business

2014

NAICS Code

32541

FW Ownership Interest

N

Employer Contact Name

Kathleen Andersen

Employer Contact Address 1

2150 E Lake Cook Rd

Employer Contact Address 2

Suite 1015

Employer Contact City

Buffalo Grove

Employer Contact State/Province

ILLINOIS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

60089

Employer Contact Phone

3129642487

Employer Contact Email

kathleen.andersen@xellia.com

Agent Attorney Name

Ife Ashabo

Agent Attorney Firm Name

Stafford Immigration Group

Agent Attorney Phone

6474945519

Agent Attorney Address 1

116 Albert Street

Agent Attorney Address 2

Suite 300

Agent Attorney City

Ottawa

Agent Attorney State/Province

Ontario

Agent Attorney Country

CANADA

Agent Attorney Postal Code

K1P 5G3

Agent Attorney Email

ife.ashabo@staffordimmigration.com

PW Track Number

P10020162640469

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level IV

PW Wage

82742.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-10-02

PW Expiration Date

2021-06-30

Wage Offer From

90900.00

Wage Offer To

0.00

Average Salary

90900.00

Wage Unit of Pay

Year

Worksite Address 1

200 Northfield Road

Worksite Address 2

Worksite City

Bedford

Worksite City Slug

bedford

Worksite State

OHIO

Worksite Postal Code

44146

Job Title

Senior Compliance Quality Assurance Specialist

Job Title Slug

senior-compliance-quality-assurance-specialist

Minimum Education

Bachelor's

Major Field of Study

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

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

In quality assurance in the pharmaceutical industry.

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Some work experience required with 1 handling quality management system of pharmaceutical products, such as change control management, deviation management, market complaint management, capa management, good documentation practices, internal audits and self assessments. 2 Pharmaceutical FDF and API manufacturing; 3 Trackwise and computer system validation; 4 Risk assessment and risk management tools, such as FMEA failure mode and effect analysis, HACCP hazard analysis and critical control points, FTA fault tree analysis, RCA root cause analysis, 5WHYS, and SWOT; and 5 CGMP current good manufacturing practice regulations enforced by the FDA.br br Job Requirements Bachelors or foreign equivalent degree in Pharmacy or related and 5 years of postdegree, progressively responsible work experience in quality assurance in the pharmaceutical industry.br br 10 domestic travel required to perform supplier audits.

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

2020-11-16

SWA Job Order End Date

2020-12-21

Sunday Edition Newspaper

Y

First Newspaper Name

Cleveland Plain Dealer

First Advertisement Start Date

2020-12-06

Second Newspaper Ad Name

Cleveland Plain Dealer

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-12-13

Employer Website From Date

2020-11-10

Employer Website To Date

2021-01-25

Professional Organization Ad From Date

2021-01-01 09:52:52

Professional Organization Advertisement To Date

2021-01-01 09:52:52

Job Search Website From Date

2020-12-11

Job Search Website To Date

2020-12-17

Employee Referral Program From Date

2021-01-01 09:52:52

Employee Referral Program To Date

2021-01-01 09:52:52

Local Ethnic Paper From Date

2020-12-10

Local Ethnic Paper To Date

2020-12-10

Radio/TV Ad From Date

2021-01-01 09:52:52

Radio/TV Ad To Date

2021-01-01 09:52:52

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

PHARMACEUTICAL SCIENCE

Foreign Worker Years of Education Completed

1999

Foreign Worker Institution of Education

VIDYABHARATI COLLEGE OF PHARMACY

Foreign Worker Education Institution Address 1

SANT GADGE BABA AMRAVATI UNIVERSITY

Foreign Worker Education Institution Address 2

CAMP AREA, NEAR TAPOVAN GATE

Foreign Worker Education Institution City

AMRAVATI

Foreign Worker Education Institution State/Province

MAHARASHTRA

Foreign Worker Education Institution Country

INDIA

Foreign Worker Education Institution Postal Code

444602

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Ife Ashabo

Preparer Title

Attorney

Preparer Email

ife.ashabo@staffordimmigration.com

Employer Information Declaration Name

Kathleen Andersen

Employer Information Declaration Title

Vice President People Organization