Fiscal Year

2022

Case Number

A-21125-82675

Case Status

Certified-Expired

Received Date

2021-07-06

Decision Date

2021-12-10

Refile

N

Original File Date

2022-01-01 10:34:28

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

P10020199720650

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level IV

PW Wage

104874.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-12-17

PW Expiration Date

2021-06-30

Wage Offer From

150972.00

Wage Offer To

0.00

Average Salary

150972.00

Wage Unit of Pay

Year

Worksite Address 1

101 Orchard Ridge Drive

Worksite Address 2

Worksite City

Gaithersburg

Worksite City Slug

gaithersburg

Worksite State

MARYLAND

Worksite Postal Code

20878

Job Title

Associate Director, R&D QA Audit

Job Title Slug

associate-director-rd-qa-audit

Minimum Education

Bachelor's

Major Field of Study

REGULATORY AFFAIRS, OR ONE OF THE MEDICAL SCIENCES (MEDICINE, PHARMACY, BIOLOGY, CHEMISTRY), 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

Master's

Accept Alternative Combination Education Years

2

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

60

Accept Alternative Job Title

QA Auditor, Compliance Manager, or a related position in the pharmaceutical industry

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

MUST HAVE BACHELORS DEGREE OR FOREIGN EQUIVALENT IN REGULATORY AFFAIRS, OR ONE OF THE MEDICAL SCIENCES MEDICINE, PHARMACY, BIOLOGY, CHEMISTRY, OR A RELATED FIELD, PLUS FIVE 5 YEARS OF PROGRESSIVELY RESPONSIBLE EXPERIENCE IN THE POSITION OFFERED, AS A QA AUDITOR, COMPLIANCE MANAGER, OR A RELATED POSITION IN THE PHARMACEUTICAL INDUSTRY. MUST HAVE FIVE 5 YEARS OF PROGRESSIVELY RESPONSIBLE EXPERIENCE IN THE FIELD OF QUALITY ASSURANCE IN THE PHARMACEUTICAL INDUSTRY PERFORMING ALL OF THE FOLLOWING DESIGNING, CONDUCTING, MANAGING AND PARTICIPATING IN REGIONAL AND GLOBAL GOOD CLINICAL PRACTICES GCP AND PHARMACOVIGILANCE PV AUDITS INCLUDING CLINICAL STUDY SITES, VENDORS, LABORATORIES, CROS, IRBS, ECS, INTERNAL SYSTEMS AND PROCEDURES, SUBMISSION DOCUMENTS OF CLINICAL AUDITS AND INSPECTIONS; MANAGING TOOLS TO TRACK, TREND, AND REPORT GCP AUDIT DATA; MONITORING ADHERENCE AND RESOLVING NONCOMPLIANCE WITH COMPANY POLICIES AND APPLICABLE REGULATIONS INCLUDING ICH, GCP, AND 21 CFR; DRAFTING REGULATIONS IN RELEVANT GXP AREAS, QUALITY STANDARDS, AND GUIDANCE AS WELL AS THE LATEST REGULATORY AUTHORITY AND INDUSTRY INTERPRETATION; PERFORMING ADHOC FOR CAUSE AUDITS TO IDENTIFY OR CONFIRM SUSPECTED NONCOMPLIANCE AND ASSIST WITH ROOT CAUSE IDENTIFICATION; PLANNING, SCHEDULING AND CONDUCTING PREAPPROVAL INSPECTION PAI READINESS ACTIVITIES; WRITING RESPONSES AND CAPAS FOR POST INSPECTION ACTIVITIES, COMMUNICATING RESULTS TO INTERNAL AND EXTERNAL CUSTOMERS; REVIEWING SOPS; PROVIDING RISK ASSESSMENT OF VENDORS, SITES AND STUDIES TO ENSURE PROPER SUPPORT OF ALL CLINICAL PROGRAMS; AND INTERFACING BETWEEN CLINICAL QA AND CLINICAL DEVELOPMENT, CLINICAL OPERATIONS, BIOSTATISTICS, PHARMACOVIGILANCE AND REGULATORY AFFAIRS TO ENSURE ALIGNMENT OF MEDICAL STRATEGY, STUDY DESIGN AND EXECUTION. ALTERNATIVELY, THE EMPLOYER WILL ACCEPT A MASTERS DEGREE OR FOREIGN EQUIVALENT IN A STATED FIELD OF STUDY PLUS TWO 2 YEARS OF EXPERIENCE, IN THE POSITION OFFERED, AS A QA AUDITOR, COMPLIANCE MANAGER OR A RELATED POSITION IN THE PHARMACEUTICAL INDUSTRY. ANY SUITABLE COMBINATION OF EDUCATION, TRAINING OR EXPERIENCE IS ACCEPTABLE.br br 25 NATIONAL AND INTERNATIONAL TRAVEL IS REQUIRED TO VARIOUS AND UNANTICIPATED COMPANY AND CLIENT SITES.

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

2021-03-08

SWA Job Order End Date

2021-04-11

Sunday Edition Newspaper

Y

First Newspaper Name

The Washington Post

First Advertisement Start Date

2021-03-14

Second Newspaper Ad Name

The Washington Post

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-03-21

Employer Website From Date

2021-03-05

Employer Website To Date

2021-06-01

Professional Organization Ad From Date

2022-01-01 10:34:28

Professional Organization Advertisement To Date

2022-01-01 10:34:28

Job Search Website From Date

2021-03-14

Job Search Website To Date

2021-03-21

Employee Referral Program From Date

2022-01-01 10:34:28

Employee Referral Program To Date

2022-01-01 10:34:28

Local Ethnic Paper From Date

2021-03-17

Local Ethnic Paper To Date

2021-03-17

Radio/TV Ad From Date

2022-01-01 10:34:28

Radio/TV Ad To Date

2022-01-01 10:34:28

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

CHINA

Foreign Worker Birth Country

CHINA

Class of Admission

L-1

Foreign Worker Education

Bachelor's

Foreign Worker Information: Major

MEDICAL SCIENCE U.S. EQUIVALENT

Foreign Worker Years of Education Completed

1999

Foreign Worker Institution of Education

BEIJING UNION UNIVERSITY

Foreign Worker Education Institution Address 1

NO. 27 DONGSISHITIAO

Foreign Worker Education Institution Address 2

DONG CHENG DISTRICT

Foreign Worker Education Institution City

BEIJING

Foreign Worker Education Institution State/Province

Foreign Worker Education Institution Country

CHINA

Foreign Worker Education Institution Postal Code

100007

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 ECHEVERRI

Employer Information Declaration Title

Global Mobility Advisor