Fiscal Year

2024

Case Number

A-23040-99749

Case Status

Certified

Received Date

2023-03-02

Decision Date

2024-05-09

Refile

N

Original File Date

2024-01-01 01:19:39

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

WAVE Life Sciences USA, Inc.

Employer Name Slug

wave-life-sciences-usa-inc

Employer Address 1

733 Concord Avenue

Employer Address 2

Employer City

Cambridge

Employer City Slug

cambridge

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

2138

Employer Phone

617-949-2900

Employer Number of Employees

248

Employer Year Commenced Business

2012

NAICS Code

541711

FW Ownership Interest

N

Employer Contact Name

Michelene Flanigon

Employer Contact Address 1

733 Concord Avenue

Employer Contact Address 2

Employer Contact City

Cambridge

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2138

Employer Contact Phone

617-949-2959

Employer Contact Email

mflanigon@wavelifesci.com

Agent Attorney Name

Bethany S Mandell

Agent Attorney Firm Name

Mandell Law Offices LLC

Agent Attorney Phone

6179398110

Agent Attorney Address 1

Mandell Law Offices

Agent Attorney Address 2

Riverside Center, 275 Grove Street, Suite 2-400

Agent Attorney City

Newton

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2466

Agent Attorney Email

bmandell@mandellimmigration.com

PW Track Number

P10022080994441

PW SOC Code

13-1041.07

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level IV

PW Wage

103875.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-09-23

PW Expiration Date

2023-06-30

Wage Offer From

103875.00

Wage Offer To

0.00

Average Salary

103875.00

Wage Unit of Pay

Year

Worksite Address 1

115 Hartwell Avenue

Worksite Address 2

Worksite City

Lexington

Worksite City Slug

lexington

Worksite State

MASSACHUSETTS

Worksite Postal Code

2421

Job Title

Quality Assurance (QA) Specialist II

Job Title Slug

quality-assurance-qa-specialist-ii

Minimum Education

Master's

Major Field of Study

Regulatory Affairs, Pharmaceutical Sciences or related field

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

5

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

36

Accept Alternative Job Title

Experience performing QA activities in a GMP environment for therapeutics research and development

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Position requires a Masters degree, or foreign equivalent in Regulatory Affairs, Pharmaceutical Sciences, or a related field plus 3 years experience performing quality assurance activities in a GMP environment for therapeutics research and development.br In the alternative, employer will accept a Bachelors degree, or foreign equivalent, in Regulatory Affairs, Pharmaceutical Sciences, or a related field plus 5 years experience performing quality assurance activities in a GMP environment for therapeutics research and development.br br The position also requires experience in the following, which may be gained concurrentlybr 1 year experience as administrator for Veeva Vault document and quality systems management QMS software modules;br 1 year experience in software validation, including but not limited to creating change controls, test plans, and executing test plans;br 1 year experience in maintaining on and offsite paper records and data including reviewing, scanning, and archiving so that they are retrievable and readable for their defined retention period;br Training as ComplianceWire administrator for GXP as demonstrated by Certificate of executed ComplianceWire Organization Administrator workshop provided by UL for any of the 3 mentioned courses ComplianceWire Security Roles, ComplianceWire Curriculum Creation and Versioning, Reporting for Audits, Control Documents and Using Quizzes, The Value of Custom Fields, ComplianceWire Assignment Best Practices, ComplianceWire Working with ILT Courses, ComplianceWire Reporting Basics, ComplianceWire Custom Exams, ComplianceWire Data Upload Tools, ComplianceWire Basic Site Configuration Options.br Required ComplianceWire Certificate may be provided through workshop, not over a period of months, thus responded quot;noquot; to question H.5 as it is not applicable

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

2022-11-04

SWA Job Order End Date

2022-12-07

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Sunday Globe

First Advertisement Start Date

2022-11-13

Second Newspaper Ad Name

The Boston Sunday Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-11-20

Employer Website From Date

2022-10-25

Employer Website To Date

2023-01-04

Professional Organization Ad From Date

2024-01-01 01:19:39

Professional Organization Advertisement To Date

2024-01-01 01:19:39

Job Search Website From Date

2022-11-10

Job Search Website To Date

2022-11-24

Employee Referral Program From Date

2024-01-01 01:19:39

Employee Referral Program To Date

2024-01-01 01:19:39

Local Ethnic Paper From Date

2022-11-15

Local Ethnic Paper To Date

2022-11-15

Radio/TV Ad From Date

2024-01-01 01:19:39

Radio/TV Ad To Date

2024-01-01 01:19:39

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

Foreign Worker Years of Education Completed

2018

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360 HUNTINGTON AVENUE

Foreign Worker Education Institution Address 2

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

Bethany S Mandell

Preparer Title

OwnerPrincipal Attorney

Preparer Email

bmandell@mandellimmigration.com

Employer Information Declaration Name

Michelene Flanigon

Employer Information Declaration Title

Senior Director, Human Resources