Previous State Work Force Agency (SWA) Case Number Stete:
Schedule A or a Sheepherder Occupation :N
Company Info
Employer Name:University at Buffalo Surgeons, Inc.
Employer Address_Line 1:462 Grider St.
Employer Address_Line 2:
Employer City :Buffalo
State:
Employer State/ Province:NEW YORK
Employer Country:UNITED STATES OF AMERICA
Employer Postal Code:14215
Employer Phone No.:716-898-5009
Employer Phone Extent No.:
Total Number of Employees:122
Employer Year of Commenced :
NAICS Code:621111
Foreign Worker Ownership & Interest:N
HR Info
Employer Contact Name:Elaine Guyton
Employer Contact Address Line1:462 Grider St.
Employer Contact Address Line2:
Employer Contact City:Buffalo
Employer Contact State/ Provice:NEW YORK
Employer Contact Country :UNITED STATES OF AMERICA
Employer Contact Post Code:14215
Employer Contact Phone:716-898-5009
Employer Contact Email:eguyton@buffalo.edu
Attorney
Agent/ Attorney Name:Rita N Georges
Agent/ Attorney Firm Name:Serotte Law Firm LLC
Agent/ Attorney Phone:7168812600
Agent/ Attorney Phone Ext.:
Agent/ Attorney Address Line 1:370 Franklin Street
Agent/ Attorney Address Line 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
Position Info
Prevailing Wage Track Number:P10020315907200
Prevailing Wage SOC Code :11-9199
Prevailing Wage SOC Title :Compliance Managers
Prevailing Wage Skill Level:Level IV
Prevailing Wage:119288
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2021-05-14
Prevailing Wage Expiration Date :2021-08-12
Wage Offer From:139859
Wage Offer To:
Wage Offer Unit of Pay:Year
Workstie Address Line 1:955 Main Street
Worksite Address Line 2:
Worksite City :Buffalo
Worksite State:NEW YORK
Worksite Postal Code:14203
Job Title:Manager β Quality Systems & Compliance
Minimum Education:Master's
Other Degree/ Diploma:
Major Field of Study:Engineering Discipline
Required Training:N
Required Training Month:
Required Field of Training:
Required Experience :Y
Required Expreience Months :60
Accept Alternate Field of Study:Y
Accept Alternate Major:Scientific Discipline
Alternate Combination of Education/ Experience:Y
Required Alternate Level of Education :Bachelor's
Other Alternate Level of Education:
Acceptable Years of Experience:8
Accept Foreign Educationa:Y
Acceptable Alternate Occupation:Y
Acceptable Alternate Occupation Month:60
Accept Alternate Job Title:Related
Normal Requirements of Job Opportunity:N
Required Foreign Language: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 Applied Foreign Worker:Y
ForeignWorker Live on Premises :N
Live in Domestic Service Worker:N
Employment Contract :
Professional Occupation :Y
College/ University Teacher:N
Competitive Process:
Basic Recruitment Process :
Teacher Select Date:
Teacher Publish Journal Name:
Additional Recruitment Information:
Job Oder Start Date:2021-01-28
Job Oder End Date:2021-02-27
Sunday Edition Newspaper:Y
First Newspaper Name:The Buffalo News
First Advertisement Start Date:2021-01-31
Second Newspaper Name:The Buffalo News
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-02-07
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:2021-01-27
Employer Website to Date:2021-02-09
Pro. Org. Ad from Date:
Pro.Org. Ad to Date:
Job Search Website from Date:2021-01-31
Job Search Website to Date:2021-02-08
Private Employment Firm from Date:
Pricate Employment Firm to Date:
Employee Referral Program from Date:
Employee Referral Program to Date:
Campus Placement from Date:
Campus Placement to Date:
Local Ethnic Newspaper from Date:2021-02-05
Local Ethnic Newspaper to Date:2021-02-05
Radio/TV Ad from Date:
Radio/TV Ad to Date:
Employer Received the Payment:N
Payment Details:
Bargaining Representative Notified:N/A
Posted Notice at Worksite:Y
Layoff in Past Six Months:N
US Worker Considered:
Country of Citizenship:INDIA
Foreign Worker Birth Country:INDIA
Class of Admission :H-1B
Employee Info
Foreign Worker Education:Master's
Foreign Worker Education Other:
Foreign Worker Major:MECHANICAL ENGINEERING
Year of Compelted Education:2014
Foreign Worker Istitution of Eduation:STATE UNIVERSITY OF NEW YORK AT BUFFALO
Foreign Worker Education Instution Address Line 1:520 LEE ROAD
Foreign Worker Education Institution Address Line 2:
Foreign Worker Education Institution City:BUFFALO
Foreign Worker Educatution Institution State:NY
Foreign Worker Education Institution Country :UNITED STATES OF AMERICA
Foreign Worker Education Training Post Code:14228
Foreign Worker Training Completion :N/A
Foreign Worker Required Experience :N
Foreign Worker Alternate Education and Experience :N
Foreign Worker Alternate Occupation Experience:Y
Foreign Worker Experience with Employer:N
Foreign Worker Employer Pay 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
