Fiscal Year

2021

Case Number

A-21034-48835

Case Status

Certified

Received Date

2021-04-29

Decision Date

2021-08-27

Refile

N

Original File Date

2021-01-01 10:05:31

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

ASTRAZENECA PHARMACEUTICALS LP

Employer Name Slug

astrazeneca-pharmaceuticals-lp

Employer Address 1

1800 CONCORD PIKE

Employer Address 2

Employer City

WILMINGTON

Employer City Slug

wilmington

Employer State

DELAWARE

Employer State Slug

delaware

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

19897

Employer Phone

302-886-3000

Employer Number of Employees

61500

Employer Year Commenced Business

1966

NAICS Code

32541

FW Ownership Interest

N

Employer Contact Name

Echeverri Adriana

Employer Contact Address 1

One MedImmune Way

Employer Contact Address 2

Employer Contact City

Gaithersburg

Employer Contact State/Province

MARYLAND

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

20878

Employer Contact Phone

301-398-0209

Employer Contact Email

adriana.echeverri@astrazeneca.com

Agent Attorney Name

Hyla K Rosenberg

Agent Attorney Firm Name

Fragomen, Del Rey, Bernsen Loewy, LLP

Agent Attorney Phone

2126888555

Agent Attorney Address 1

1400 Broadway

Agent Attorney Address 2

Agent Attorney City

New York

Agent Attorney State/Province

NEW YORK

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

10018

Agent Attorney Email

acharniauskaya@fragomen.com

PW Track Number

P10020133564643

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialist

PW Skill Level

Level IV

PW Wage

104874.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-08-27

PW Expiration Date

2021-06-30

Wage Offer From

106542.00

Wage Offer To

0.00

Average Salary

106542.00

Wage Unit of Pay

Year

Worksite Address 1

633 Research Court

Worksite Address 2

Worksite City

Frederick

Worksite City Slug

frederick

Worksite State

MARYLAND

Worksite Postal Code

21703

Job Title

Quality Assurance Specialist IV

Job Title Slug

quality-assurance-specialist-iv

Minimum Education

Master's

Major Field of Study

Biotechnology, Pharmacy or rel

Required Training

N

Required Experience

Y

Required Experience Months

60

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

7

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

60

Accept Alternative Job Title

Biotechpharmaceutical industry as a Quality Assurance Analyst, QA Auditor or rel

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Must possess a Masters degree or foreign equivalent in Biotechnology, Pharmacy or a related field of study plus five 5 years of experience in the biotechpharmaceutical industry in offered role or as a Quality Assurance Analyst, QA Auditor or a related position. Must possess five 5 years of experience in the biotechpharmaceutical Quality Assurance sector with FDA regulations including 21 CFR 210, 211, and 11; ICH guidelines; cleaning validation; equipment calibration and qualification; QA Lot disposition and release; QA compliance, audit, and inspection; validation and quality control; flow of material, personnel and equipment with production modules; gap analysis; risk assessment; deviation management system TrackWise QMS; electronic document management system; recording, reporting, assessing, and reviewing alarm reports to control critical batch parameters for clinical, commercial, and validation runs; Biotechnology processes including fermentation, harvest, purification and formulation at commercial and clinical stage; SAP; lean tools including DMAIC, FMEA HERCA and six sigma certified yellow belt; and Quality Metric management using various databases and MS applications. In the alternative, the employer will accept a Bachelors degree or foreign equivalent in a stated field of study plus seven 7 years of progressively responsible experience in the biotechpharmaceutical industry, 5 of which must have been as a Quality Assurance Validation Analyst, QA Auditor or a related position and seven 7 years experience in the above skill areas. The employer will accept pre or postMasters degree experience. Any suitable combination of education, training, or experience is acceptable. Must be able to work 12 hour weekend shift 600PM to 630AM Saturday, Sunday, Monday.

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

2020-12-10

SWA Job Order End Date

2021-01-12

Sunday Edition Newspaper

Y

First Newspaper Name

The Washington Post

First Advertisement Start Date

2020-12-20

Second Newspaper Ad Name

The Washington Post

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-12-27

Employer Website From Date

2020-12-01

Employer Website To Date

2021-02-16

Professional Organization Ad From Date

2021-01-01 10:05:31

Professional Organization Advertisement To Date

2021-01-01 10:05:31

Job Search Website From Date

2020-12-20

Job Search Website To Date

2021-01-03

Employee Referral Program From Date

2021-01-01 10:05:31

Employee Referral Program To Date

2021-01-01 10:05:31

Local Ethnic Paper From Date

2020-12-24

Local Ethnic Paper To Date

2020-12-30

Radio/TV Ad From Date

2021-01-01 10:05:31

Radio/TV Ad To Date

2021-01-01 10:05:31

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

CANADA

Foreign Worker Birth Country

PAKISTAN

Class of Admission

H-1B

Foreign Worker Education

Master's

Foreign Worker Information: Major

BIOTECHNOLOGY AND MANAGEMENT

Foreign Worker Years of Education Completed

2018

Foreign Worker Institution of Education

MOUNT ST. MARYS UNIVERSITY

Foreign Worker Education Institution Address 1

16300 OLD EMMITSBURG RD

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

EMMITSBURG

Foreign Worker Education Institution State/Province

MD

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

21727

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Hyla K Rosenberg

Preparer Title

Partner

Preparer Email

acharniauskaya@fragomen.com

Employer Information Declaration Name

Adriana Echevveri

Employer Information Declaration Title

Global Mobility Advisor