Previous State Work Force Agency (SWA) Case Number Stete:
Schedule A or a Sheepherder Occupation :N
Company Info
Employer Name:INGENUS PHARMACEUTICALS, NJ, LLC
Employer Address_Line 1:140 NEW DUTCH LN
Employer Address_Line 2:
Employer City :FAIRFIELD
State:
Employer State/ Province:NEW JERSEY
Employer Country:UNITED STATES OF AMERICA
Employer Postal Code:7004
Employer Phone No.:973-830-3285
Employer Phone Extent No.:
Total Number of Employees:107
Employer Year of Commenced :
NAICS Code:325412
Foreign Worker Ownership & Interest:N
HR Info
Employer Contact Name:Tammy Michaud
Employer Contact Address Line1:140 New Dutch Ln
Employer Contact Address Line2:
Employer Contact City:Fairfield
Employer Contact State/ Provice:NEW JERSEY
Employer Contact Country :UNITED STATES OF AMERICA
Employer Contact Post Code:7004
Employer Contact Phone:973-830-3285
Employer Contact Email:tmichaud@ingenus.com
Attorney
Agent/ Attorney Name:David H Nachman
Agent/ Attorney Firm Name:NPZ Law Group, P.C.
Agent/ Attorney Phone:2016700006
Agent/ Attorney Phone Ext.:100
Agent/ Attorney Address Line 1:487 Goffle Road
Agent/ Attorney Address Line 2:Visaserve Plaza
Agent/ Attorney City:Ridgewood
Agent/ Attorney State/ Province:NEW JERSEY
Agent/ Attorney Country:UNITED STATES OF AMERICA
Agent/ Attorney Postal Code:7450
Agent/ Attorney Email:david_nachman@visaserve.com
Position Info
Prevailing Wage Track Number:P10021028040764
Prevailing Wage SOC Code :13-1041
Prevailing Wage SOC Title :Regulatory Affairs Specialists
Prevailing Wage Skill Level:Level II
Prevailing Wage:69139
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2021-06-14
Prevailing Wage Expiration Date :2021-09-12
Wage Offer From:73861
Wage Offer To:
Wage Offer Unit of Pay:Year
Workstie Address Line 1:140 New Dutch Lane
Worksite Address Line 2:
Worksite City :Fairfield
Worksite State:NEW JERSEY
Worksite Postal Code:7004
Job Title:QA Associate (Compliance and Regulatory Affairs)
Minimum Education:Master's
Other Degree/ Diploma:
Major Field of Study:Regulatory Affairs of Drugs, Biologics and Medical Devices
Required Training:N
Required Training Month:
Required Field of Training:
Required Experience :Y
Required Expreience Months :24
Accept Alternate Field of Study:Y
Accept Alternate Major:Pharmaceutical Sciences
Alternate Combination of Education/ Experience:N
Required Alternate Level of Education :
Other Alternate Level of Education:
Acceptable Years of Experience:
Accept Foreign Educationa:Y
Acceptable Alternate Occupation:N
Acceptable Alternate Occupation Month:
Accept Alternate Job Title:
Normal Requirements of Job Opportunity:Y
Required Foreign Language:N
Specific Skills:MASTER OF SCIENCE DEGREE IN REGULATORY AFFAIRS OF DRUGS, BIOLOGICS AND MEDICAL DEVICES OR PHARMACEUTICAL SCIENCES AND TWO 2 YEARS OFbr EXPERIENCE IN QUALITY ASSURANCE WITHIN A GENERIC PHARMACEUTICAL ENVIRONMENT. APPLICANT MUST HAVE HANDSON EXPERIENCE IN PREPARING ANDbr REVIEWING CMC AND LABELING FOR REGULATORY FILINGS AND OTHER REGULATORY SUBMISSIONS WITH USFDA. MUST HAVE DEMONSTRATE EXPERTISE INbr DEVELOPING AND REVIEWING SOPS, CAPA, CHANGE CONTROLS, DEVIATIONS, MASTER BATCH RECORD, LAB REPORTS AND RISK ANALYSIS DOCUMENTS WITHbr ACCURACY AND MAINTAINING COMPLIANCE WITH TITLE 21 CFR 211, CGMP REGULATIONS, FDA, CFR AND ICH GUIDELINES. MUST BE PROFICIENT IN APPLICABLECOMPUTER AND DATABASE APPLICATIONS INCLUDING MS WORD, MS EXCEL, PDF, ECTD SUBMISSIONS SOFTWARE, AND LABELING DESIGN SOFTWARE.
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:2021-07-16
Job Oder End Date:2021-08-18
Sunday Edition Newspaper:Y
First Newspaper Name:The Star Ledger
First Advertisement Start Date:2021-08-22
Second Newspaper Name:The Star Ledger
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-08-29
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:
Employer Website to Date:
Pro. Org. Ad from Date:
Pro.Org. Ad to Date:
Job Search Website from Date:2021-08-22
Job Search Website to Date:2021-09-05
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:2021-08-26
Local Ethnic Newspaper to Date:2021-08-26
Radio/TV Ad from Date:2021-08-27
Radio/TV Ad to Date:2021-08-27
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:REGULATORY AFFAIRS FOR DRUGS, BIOLOGICS MEDICAL DEVICES
Year of Compelted Education:2013
Foreign Worker Istitution of Eduation:NORTHEASTERN UNIVERSITY
Foreign Worker Education Instution Address Line 1:360 HUNTINGTON AVE
Foreign Worker Education Institution Address Line 2:
Foreign Worker Education Institution City:BOSTON
Foreign Worker Educatution Institution State:MA
Foreign Worker Education Institution Country :UNITED STATES OF AMERICA
Foreign Worker Education Training Post Code:2115
Foreign Worker Training Completion :N/A
Foreign Worker Required Experience :Y
Foreign Worker Alternate Education and Experience :N/A
