Fiscal Year

2023

Case Number

A-22045-11100

Case Status

Certified

Received Date

2022-04-15

Decision Date

2022-12-29

Refile

N

Original File Date

2023-01-01 17:56:49

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Karuna Therapeutics

Employer Name Slug

karuna-therapeutics

Employer Address 1

99 High Street

Employer Address 2

Floor 26

Employer City

Boston

Employer City Slug

boston

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

2110

Employer Phone

857-449-2244

Employer Number of Employees

88

Employer Year Commenced Business

2009

NAICS Code

541711

FW Ownership Interest

N

Employer Contact Name

Stephanie Moore

Employer Contact Address 1

99 High Street

Employer Contact Address 2

Floor 26

Employer Contact City

Boston

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2110

Employer Contact Phone

857-449-2244

Employer Contact Email

skmoore@karunatx.com

Agent Attorney Name

Donald W Parker

Agent Attorney Firm Name

Parker Gallini LLP

Agent Attorney Phone

7818108990

Agent Attorney Address 1

460 Totten Pond Road

Agent Attorney Address 2

Suite 350

Agent Attorney City

Waltham

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2451

Agent Attorney Email

dparker@parkergallini.com

PW Track Number

P10021217504636

PW SOC Code

11-3051

PW SOC Title

Industrial Production Managers

PW Skill Level

Level IV

PW Wage

169749.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-01-31

PW Expiration Date

2022-06-30

Wage Offer From

169749.00

Wage Offer To

0.00

Average Salary

169749.00

Wage Unit of Pay

Year

Worksite Address 1

99 High Street

Worksite Address 2

Floor 26

Worksite City

Boston

Worksite City Slug

boston

Worksite State

MASSACHUSETTS

Worksite Postal Code

2110

Job Title

Senior Manager, Quality Assurance, CMC

Job Title Slug

senior-manager-quality-assurance-cmc

Minimum Education

Master's

Major Field of Study

Pharmaceutical Sciences, Chemistry or related science 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

N

Accept Alternative Combination Education

Accept Alternative Combination Education Years

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

96

Accept Alternative Job Title

See H.14.

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

This position requires a Masters degree or an equivalent foreign degree in Pharmaceutical Sciences, Chemistry or related science field and 8 years of experience as a Quality Assurance Analyst or Quality Control Analyst in the Pharmaceutical or Biotechnology industry in an operational Quality role.br br Must also have 8 years of experience which can have been gained concurrently with the primary experience requirement above working with the followingbr 21 CFR 201211 and ICH Q7, cGMP regulations and ICH;br Leading readiness activities during, and participating in, FDA and EMA inspections and audits;br Writing and approving DeviationsOOSOOTCAPAchange control reports;br Managing vendor qualification activities and vendor audits and establishing Quality Agreements with contract manufacturers or testing laboratories;br Conducting annual product reviews with drug substance and drug product vendors;br Handling product quality complaints and overseeing investigations and root cause analyses;br General analytical techniques including GC, LC, KF, NMR, LOD.br br Will accept any qualified combination of education, training andor experience.br br From H.10.B., Job title of the acceptable occupation Quality Assurance Analyst or Quality Control Analyst in the Pharmaceutical or Biotechnology industry in an operational Quality role.

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

2022-02-09

SWA Job Order End Date

2022-03-15

Sunday Edition Newspaper

Y

First Newspaper Name

Boston Globe

First Advertisement Start Date

2022-02-20

Second Newspaper Ad Name

Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-02-27

Employer Website From Date

2023-01-01 17:56:49

Employer Website To Date

2023-01-01 17:56:49

Professional Organization Ad From Date

2023-01-01 17:56:49

Professional Organization Advertisement To Date

2023-01-01 17:56:49

Job Search Website From Date

2022-02-17

Job Search Website To Date

2022-02-24

Employee Referral Program From Date

2023-01-01 17:56:49

Employee Referral Program To Date

2023-01-01 17:56:49

Local Ethnic Paper From Date

2022-02-22

Local Ethnic Paper To Date

2022-02-24

Radio/TV Ad From Date

2023-01-01 17:56:49

Radio/TV Ad To Date

2023-01-01 17:56:49

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

PHARMACEUTICAL SCIENCESPHARMACOLOGY

Foreign Worker Years of Education Completed

2009

Foreign Worker Institution of Education

LONG ISLAND UNIVERSITY

Foreign Worker Education Institution Address 1

700 NORTHERN BLVD.

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BROOKVILLE

Foreign Worker Education Institution State/Province

NY

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

11548

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Donald W Parker

Preparer Title

Attorney

Preparer Email

dparker@parkergallini.com

Employer Information Declaration Name

Troy Ignelzi

Employer Information Declaration Title

Chief Financial Officer