Fiscal Year

2021

Case Number

A-20189-73417

Case Status

Certified-Expired

Received Date

2020-07-27

Decision Date

2021-03-01

Refile

N

Original File Date

2021-01-01 09:03:55

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

AGC BIOLOGICS, INC

Employer Name Slug

agc-biologics-inc

Employer Address 1

21511 23RD DR. SE

Employer Address 2

Employer City

BOTHELL

Employer City Slug

bothell

Employer State

WASHINGTON

Employer State Slug

washington

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

98021

Employer Phone

425-485-1900

Employer Number of Employees

315

Employer Year Commenced Business

2007

NAICS Code

325414

FW Ownership Interest

N

Employer Contact Name

Kris Reeter

Employer Contact Address 1

21511 23rd Dr. SE

Employer Contact Address 2

Employer Contact City

Bothell

Employer Contact State/Province

WASHINGTON

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

98021

Employer Contact Phone

(425) 415-5399

Employer Contact Email

kreeter@agcbio.com

Agent Attorney Name

Felicia L Gittleman

Agent Attorney Firm Name

Cowan Miller Lederman

Agent Attorney Phone

2063401033

Agent Attorney Address 1

1000 Second Avenue

Agent Attorney Address 2

Suite 1620

Agent Attorney City

Seattle

Agent Attorney State/Province

WASHINGTON

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

98104

Agent Attorney Email

fgittleman@cmlseattle.com

PW Track Number

P10019301112352

PW SOC Code

11-3051

PW SOC Title

Quality Control Systems Managers

PW Skill Level

Level II

PW Wage

112778.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-02-25

PW Expiration Date

2020-06-30

Wage Offer From

127720.00

Wage Offer To

137720.00

Average Salary

132720.00

Wage Unit of Pay

Year

Worksite Address 1

21511 23rd Dr SE

Worksite Address 2

Worksite City

Bothell

Worksite City Slug

bothell

Worksite State

WASHINGTON

Worksite Postal Code

98021

Job Title

Quality Control Systems Manager

Job Title Slug

quality-control-systems-manager

Minimum Education

Bachelor's

Major Field of Study

Chemistry, or a related life 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

36

Accept Alternative Job Title

Any job title providing required experience outlined in box H14.

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Bachelors degree in Chemistry, or a related life science field, or the foreign degree equivalent; and 3 years of experience in Plan, execute and followup on client audits and regulatory inspections for commercial and clinical protein therapeutics manufacturing sites to ensure cGMP compliance; Develop, implement, and maintain Quality Systems and SOPs to enable cGMP compliant and inspection readiness of sites for commercial and clinical protein therapeutics manufacture; Utilize electronic systems, including Excel, Audit Utopia, Word, TrackWise, Master Control, and PowerPoint, to support monitoring of including developing and utilizing metrics and develop reports related to site inspection readiness and site compliance risks; Collaborate with crossfunctional teams to develop and support timely submission of leadershipapproved written responses to both regulatory agencies FDA, MHRA, EMA, PMDA and clients in response to inspection observations; and Coordinate, manage and conduct inspection readiness activities, and take actions to ensure that leadership, management, and staff have a full understanding of relevant FDA and other agency regulations, concerns and trends related to prelicensing and preapproval inspections for protein therapeutics manufacturing. Experience may be gained concurrently.

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

2020-05-22

SWA Job Order End Date

2020-06-26

Sunday Edition Newspaper

Y

First Newspaper Name

The Seattle Times

First Advertisement Start Date

2020-05-24

Second Newspaper Ad Name

The Seattle Times

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-05-31

Employer Website From Date

2021-01-01 09:03:55

Employer Website To Date

2021-01-01 09:03:55

Professional Organization Ad From Date

2021-01-01 09:03:55

Professional Organization Advertisement To Date

2021-01-01 09:03:55

Job Search Website From Date

2020-05-27

Job Search Website To Date

2020-06-08

Employee Referral Program From Date

2021-01-01 09:03:55

Employee Referral Program To Date

2021-01-01 09:03:55

Local Ethnic Paper From Date

2020-05-29

Local Ethnic Paper To Date

2020-05-29

Radio/TV Ad From Date

2021-01-01 09:03:55

Radio/TV Ad To Date

2021-01-01 09:03:55

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

SPAIN

Foreign Worker Birth Country

SPAIN

Class of Admission

L-1

Foreign Worker Education

Bachelor's

Foreign Worker Information: Major

CHEMISTRY

Foreign Worker Years of Education Completed

2006

Foreign Worker Institution of Education

AUTONOMOUS UNIVERSITY OF MADRID

Foreign Worker Education Institution Address 1

CIUDAD UNIVERSITARIA OF CANTOBLANCO

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

MADRID

Foreign Worker Education Institution State/Province

Foreign Worker Education Institution Country

SPAIN

Foreign Worker Education Institution Postal Code

28049

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Felicia L Gittleman

Preparer Title

Attorney

Preparer Email

fgittleman@cmlseattle.com

Employer Information Declaration Name

Kris Reeter

Employer Information Declaration Title

Senior HRBP