RICONPHARMA LLC

Assistant Manager, QA

A-22284-37309 H-1B 2023 Certified

Salary

$72,634

Visa Type

H-1B

Job Title

Assistant Manager, QA

Employee's Citizenship

INDIA

Graduate School

NORTHEASTERN UNIVERSITY

Case info Company Info HR Info Attorney Position Info Employee Info

Case info

9 fields

Data Publish Year 2023

Case Number A-22284-37309

Case Status Certified

Received Date 2022-11-09

Decision Date 2023-09-22

Refile N

Original File Date -

Previous State Work Force Agency (SWA) Case Number Stete -

Schedule A or a Sheepherder Occupation N

Company Info

14 fields

Employer Name RICONPHARMA LLC

Employer Address_Line 1 100 FORD ROAD

Employer Address_Line 2 SUITE 9

Employer City DENVILLE

State -

Employer State/ Province NEW JERSEY

Employer Country UNITED STATES OF AMERICA

Employer Postal Code 7834

Employer Phone No. 9738303285

Employer Phone Extent No. -

Total Number of Employees 85

Employer Year of Commenced 2008

NAICS Code 325412

Foreign Worker Ownership & Interest N

HR Info

9 fields

Employer Contact Name Tammy Michaud

Employer Contact Address Line1 100 Ford Road

Employer Contact Address Line2 Suite 9

Employer Contact City Denville

Employer Contact State/ Provice NEW JERSEY

Employer Contact Country UNITED STATES OF AMERICA

Employer Contact Post Code 7834

Employer Contact Phone 9738303285

Employer Contact Email tmichaud@ingenus.com

Attorney

11 fields

Agent/ Attorney Name David H Nachman

Agent/ Attorney Firm Name NPZ Law Group, P.C.

Agent/ Attorney Phone 2016700006

Agent/ Attorney Phone Ext. -

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

89 fields

Prevailing Wage Track Number P10021327723017

Prevailing Wage SOC Code 13-1041

Prevailing Wage SOC Title Compliance Officers

Prevailing Wage Skill Level Level II

Prevailing Wage 72634

Prevailing Wage Unit of Pay Year

Prevailing Wage Source OES

Prevailing Wage Other Source -

Prevailing Wage Determination Date 2022-06-02

Prevailing Wage Expiration Date 2022-08-31

Wage Offer From 82500

Wage Offer To -

Wage Offer Unit of Pay Year

Workstie Address Line 1 100 Ford Road

Worksite Address Line 2 Suite#9

Worksite City Denville

Worksite State NEW JERSEY

Worksite Postal Code 7834

Job Title Assistant Manager, QA

Minimum Education Master's

Other Degree/ Diploma -

Major Field of Study Pharmacy

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 Regulatory Affairs or Project Management with concentration in Regulatory Affairs

Alternate Combination of Education/ Experience N

Required Alternate Level of Education -

Other Alternate Level of Education -

Acceptable Years of Experience -

Accept Foreign Educationa N

Acceptable Alternate Occupation N

Acceptable Alternate Occupation Month -

Accept Alternate Job Title -

Normal Requirements of Job Opportunity Y

Required Foreign Language N

Specific Skills Must have a Masters degree in Pharmacy, Regulatory Affairs or Project Management with concentration in Regulatory Affairs. Must have 2 years experience in the fields of Regulatory Affairs and Quality Assurance within a generic pharmaceutical environment. Must have prior experience in preparing and reviewing electronic publishing and filing various types of regulatory submissions DMF ANDA NDA 505 b2 IND including amendments, supplements, and presubmission documentation with USFDA. Experience in generic drug filings to the USFDA with expertise in CMC, structured product labeling, establishment registrations, Validation and eCTD publishing is required. Strong knowledge in Pharmaceutical Development of Immediate Release Tablets, ExtendedRelease Tablets, Transdermal Patches, Topical Aerosols sprays, Ointments, Creams, Gels, Nasal Sprays, and Topical Solutions is required. Knowledge of Code of federal regulations Title 21, Part 314 and applicable subparts and relevant FDA guidances, ICH guidelines including GLP and cGMP regulations. Strong attention to details. Must be able to prioritize assigned development of multiple projects. Demonstrate acceptable skills in oral and written communications, independent judgment, teaching and training, problem solvingdecision making, adhering to timelines, negotiation skills, integrity and adaptability.

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 2022-06-16

Job Oder End Date 2022-07-20

Sunday Edition Newspaper Y

First Newspaper Name The Star Ledger

First Advertisement Start Date 2022-07-24

Second Newspaper Name The Star Ledger

Second Advertisement Type Newspaper

Second Ad Start Date 2022-07-31

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 2022-08-20

Job Search Website to Date 2022-09-05

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 2022-07-27

Local Ethnic Newspaper to Date 2022-07-27

Radio/TV Ad from Date 2022-08-09

Radio/TV Ad to Date 2022-08-09

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

24 fields

Foreign Worker Education Master's

Foreign Worker Education Other -

Foreign Worker Major PROJECT MANAGEMENT DRUG REGULATORY AFFAIRS CONCENTRATION

Year of Compelted Education 2017

Foreign Worker Istitution of Eduation NORTHEASTERN UNIVERSITY

Foreign Worker Education Instution Address Line 1 360 HUNTINGTON AVENUE

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 02115-5000

Foreign Worker Training Completion N/A

Foreign Worker Required Experience Y

Foreign Worker Alternate Education and Experience N/A

Foreign Worker Alternate Occupation Experience N/A

Foreign Worker Experience with Employer N

Foreign Worker Employer Pay for Education N

Foreign Worker Currently Employed Y

Employer Completed Application N

Preparer Name David H Nachman

Preparer Title Managing Attorney

Preparer Email david_nachman@visaserve.com

Employer Information Declaration Name Tammy Michaud

Employer Declaration Title Sr. Director, HR