Fiscal Year

2022

Case Number

A-21193-15885

Case Status

Certified-Expired

Received Date

2021-07-26

Decision Date

2021-12-28

Refile

N

Original File Date

2022-01-01 10:40:59

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

AGIOS PHARMACEUTICALS, INC.

Employer Name Slug

agios-pharmaceuticals-inc

Employer Address 1

88 SIDNEY STREET

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

2139

Employer Phone

6176498600

Employer Number of Employees

450

Employer Year Commenced Business

2008

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Alison Connelly

Employer Contact Address 1

88 Sidney Street

Employer Contact Address 2

Employer Contact City

Cambridge

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2139

Employer Contact Phone

6173528588

Employer Contact Email

ali.connelly@agios.com

Agent Attorney Name

Robert Webber

Agent Attorney Firm Name

Dorsey Whitney LLP

Agent Attorney Phone

6124926715

Agent Attorney Address 1

50 South Sixth Street

Agent Attorney Address 2

Suite 1500

Agent Attorney City

Minneapolis

Agent Attorney State/Province

MINNESOTA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

55402

Agent Attorney Email

Webber.Robert@dorsey.com

PW Track Number

P10020234780956

PW SOC Code

11-9199

PW SOC Title

Managers, All Other

PW Skill Level

Level III

PW Wage

135554.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-01-27

PW Expiration Date

2021-06-30

Wage Offer From

135554.00

Wage Offer To

0.00

Average Salary

135554.00

Wage Unit of Pay

Year

Worksite Address 1

88 Sidney Street

Worksite Address 2

Worksite City

Cambridge

Worksite City Slug

cambridge

Worksite State

MASSACHUSETTS

Worksite Postal Code

2139

Job Title

Manager, Digital Quality and Data Integrity

Job Title Slug

manager-digital-quality-and-data-integrity

Minimum Education

Master's

Major Field of Study

Regulatory Affairs, Pharm Sciences, clsly rel. 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

N

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

24

Accept Alternative Job Title

Quality AssuranceValidation Engineering e.g. Validation Tester, Validation Engineer

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Position requires at least a Masters degree in Regulatory Affairs, Pharmaceutical Sciences, or closely related field. Qualified candidate must have at least 2 years 24 months of Quality AssuranceValidation Engineering experience in the pharmaceutical field. Qualified candidate must have at least 1 year 12 months of experience a ensuring US FDA regulationsguidelinescompliance such as 21 CRF 11, 21 CRF 210, 21 CRF 211, 21 CRF 820, ISO 13485, ISO 14971, GAMP 5, ICH, SOX testingcompliance are met, b performing and managing compliance based GxP validation projects, c ensuring GxP computer systems are designed, validated, and maintained in an appropriately risked based and compliant state throughout the entire systems and data lifecycles, d creating, maintaining, reviewing and revising quality systems and procedures to ensure GxP computer systems are operated and maintained in a validated and continual state of inspection readiness with regards to cGxP, e ensuring GxP requirements are aligned with applicable regulatory requirements and internal procedures and Health Authority Regulations, and f preparing various validation protocols such as validation plans, test scripts in accordance to SOPs. Position requires domesticforeign travel up to 5 as needed and customary for the occupation. All experience may be gained concurrently. Employer will accept candidates with any suitable combination of education and experience as described in H4 to H10, above.

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

2021-03-26

SWA Job Order End Date

2021-04-30

Sunday Edition Newspaper

Y

First Newspaper Name

Boston Globe

First Advertisement Start Date

2021-04-04

Second Newspaper Ad Name

Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-04-11

Employer Website From Date

2021-03-30

Employer Website To Date

2021-04-07

Professional Organization Ad From Date

2022-01-01 10:40:59

Professional Organization Advertisement To Date

2022-01-01 10:40:59

Job Search Website From Date

2021-04-05

Job Search Website To Date

2021-04-12

Employee Referral Program From Date

2022-01-01 10:40:59

Employee Referral Program To Date

2022-01-01 10:40:59

Local Ethnic Paper From Date

2021-04-08

Local Ethnic Paper To Date

2021-04-08

Radio/TV Ad From Date

2022-01-01 10:40:59

Radio/TV Ad To Date

2022-01-01 10:40:59

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

2013

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

Robert P Webber

Preparer Title

Attorney

Preparer Email

webber.robert@dorsey.com

Employer Information Declaration Name

Ali Connelly

Employer Information Declaration Title

Associate Manager, HR Operations