Fiscal Year

2022

Case Number

A-21082-65354

Case Status

Certified-Expired

Received Date

2021-05-17

Decision Date

2021-10-07

Refile

N

Original File Date

2022-01-01 10:15:18

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

University at Buffalo Surgeons, Inc.

Employer Name Slug

university-at-buffalo-surgeons-inc

Employer Address 1

462 Grider St.

Employer Address 2

Employer City

Buffalo

Employer City Slug

buffalo

Employer State

NEW YORK

Employer State Slug

new-york

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

14215

Employer Phone

716-898-5009

Employer Number of Employees

122

Employer Year Commenced Business

2001

NAICS Code

621111

FW Ownership Interest

N

Employer Contact Name

Elaine Guyton

Employer Contact Address 1

462 Grider St.

Employer Contact Address 2

Employer Contact City

Buffalo

Employer Contact State/Province

NEW YORK

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

14215

Employer Contact Phone

716-898-5009

Employer Contact Email

eguyton@buffalo.edu

Agent Attorney Name

Rita N Georges

Agent Attorney Firm Name

Serotte Law Firm LLC

Agent Attorney Phone

7168812600

Agent Attorney Address 1

370 Franklin Street

Agent Attorney Address 2

Agent Attorney City

Buffalo

Agent Attorney State/Province

NEW YORK

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

14202

Agent Attorney Email

rgeorges@serottelaw.com

PW Track Number

P10020315907200

PW SOC Code

11-9199

PW SOC Title

Compliance Managers

PW Skill Level

Level IV

PW Wage

119288.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-05-14

PW Expiration Date

2021-08-12

Wage Offer From

139859.00

Wage Offer To

0.00

Average Salary

139859.00

Wage Unit of Pay

Year

Worksite Address 1

955 Main Street

Worksite Address 2

Worksite City

Buffalo

Worksite City Slug

buffalo

Worksite State

NEW YORK

Worksite Postal Code

14203

Job Title

Manager – Quality Systems & Compliance

Job Title Slug

manager-quality-systems-compliance

Minimum Education

Master's

Major Field of Study

Engineering Discipline

Required Training

N

Required Experience

Y

Required Experience Months

60

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Scientific Discipline

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

8

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

60

Accept Alternative Job Title

Related

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Experience must have included; Working with FDA regulated GxP environment in a Medical device, pharmaceutical or Life sciences Industry and generating technical reports for FDA 510k submission; Qualification and functionalizing of Quality Management System QMS and conducting periodic quality reviews and audits in a developmental and nonclinical environment and develop compliance plan to meet HIPAA requirements; Configure and functionalize eQMS and LIMS compliant with 21 CFR Part 11 including vendor selection, qualification, development of service agreements and setting up appropriate processes to enable receipt and testing of biological samples; Training and guiding direct and nondirect reports in GxP Good manufacturing Clinical Lab practice processes and procedures; eQMS and LIMS; Liaise with Department of Health, accreditation bodies to qualify laboratories and Host external regulatory agencies, thirdparty entities for audits and resolve audit findings; Managing nonconformance investigation, CAPAs, conducting deviation assessment and risk management activities in a FDA regulated environment within medical device, pharmaceutical or Life sciences Industry, with associated root cause analysis using Fishbone, FMEA Failure Mode Effect, KepnerTregoe and 5 Why analysis; Qualifying, working in and monitoring a controlled environment BSL23, clean room and associated ancillaries within an FDA regulated Pharmaceutical, medical device or life sciences industry; Perform technical writing to generate Standard Operating procedures, protocols, Quality policies, inspection reports and define management responsibilities; and Performing installation, operational and performance qualification IQ,OQ,PQ on complex biotechnological equipment e.g. ventilators, patient monitors, automated blood fractionation and liquid handling machine, automated cryogenic sample storage and development of associated preventive maintenance and calibration programs.

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

2021-01-28

SWA Job Order End Date

2021-02-27

Sunday Edition Newspaper

Y

First Newspaper Name

The Buffalo News

First Advertisement Start Date

2021-01-31

Second Newspaper Ad Name

The Buffalo News

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-02-07

Employer Website From Date

2021-01-27

Employer Website To Date

2021-02-09

Professional Organization Ad From Date

2022-01-01 10:15:18

Professional Organization Advertisement To Date

2022-01-01 10:15:18

Job Search Website From Date

2021-01-31

Job Search Website To Date

2021-02-08

Employee Referral Program From Date

2022-01-01 10:15:18

Employee Referral Program To Date

2022-01-01 10:15:18

Local Ethnic Paper From Date

2021-02-05

Local Ethnic Paper To Date

2021-02-05

Radio/TV Ad From Date

2022-01-01 10:15:18

Radio/TV Ad To Date

2022-01-01 10:15:18

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

MECHANICAL ENGINEERING

Foreign Worker Years of Education Completed

2014

Foreign Worker Institution of Education

STATE UNIVERSITY OF NEW YORK AT BUFFALO

Foreign Worker Education Institution Address 1

520 LEE ROAD

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BUFFALO

Foreign Worker Education Institution State/Province

NY

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

14228

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

N

Employer Completed Application

N

Preparer Name

RITA N GEORGES

Preparer Title

ATTORNEY

Preparer Email

RGEORGES@SEROTTELAW.COM

Employer Information Declaration Name

STEVEN SCHWAITZBERG

Employer Information Declaration Title

PRESIDENT