Novel Laboratories Inc.

Senior Manager, Quality Systems

A-23082-17680 H-1B 2023 Withdrawn

Salary

$173,410

Visa Type

H-1B

Job Title

Senior Manager, Quality Systems

Employee's Citizenship

INDIA

Graduate School

SARDAR PATEL UNIVERSITY

Case info Company Info HR Info Attorney Position Info Employee Info

Case info

9 fields

Data Publish Year 2023

Case Number A-23082-17680

Case Status Withdrawn

Received Date 2023-04-19

Decision Date 2023-06-02

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 Novel Laboratories Inc.

Employer Address_Line 1 400 Campus Drive

Employer Address_Line 2 -

Employer City Somerset

State -

Employer State/ Province NEW JERSEY

Employer Country UNITED STATES OF AMERICA

Employer Postal Code 8873

Employer Phone No. 9086036000

Employer Phone Extent No. 6063

Total Number of Employees 382

Employer Year of Commenced 2007

NAICS Code 32541

Foreign Worker Ownership & Interest N

HR Info

9 fields

Employer Contact Name Prakash Salunke

Employer Contact Address Line1 400 Campus Drive

Employer Contact Address Line2 -

Employer Contact City Somerset

Employer Contact State/ Provice NEW JERSEY

Employer Contact Country UNITED STATES OF AMERICA

Employer Contact Post Code 8873

Employer Contact Phone 9086036000 6063

Employer Contact Email prakashsalunke@lupin.com

Attorney

11 fields

Agent/ Attorney Name Erin Hogan

Agent/ Attorney Firm Name Quarles Brady LLP

Agent/ Attorney Phone 3127155248

Agent/ Attorney Phone Ext. -

Agent/ Attorney Address Line 1 300 N. LaSalle Street

Agent/ Attorney Address Line 2 Suite 4000

Agent/ Attorney City Chicago

Agent/ Attorney State/ Province ILLINOIS

Agent/ Attorney Country UNITED STATES OF AMERICA

Agent/ Attorney Postal Code 60654

Agent/ Attorney Email Erin.Hogan@quarles.com

Position Info

89 fields

Prevailing Wage Track Number P10022032869655

Prevailing Wage SOC Code 11-3051.01

Prevailing Wage SOC Title Quality Control Systems Manager

Prevailing Wage Skill Level Level IV

Prevailing Wage 173410

Prevailing Wage Unit of Pay Year

Prevailing Wage Source OES

Prevailing Wage Other Source -

Prevailing Wage Determination Date 2022-11-30

Prevailing Wage Expiration Date 2023-06-30

Wage Offer From 173410

Wage Offer To -

Wage Offer Unit of Pay Year

Workstie Address Line 1 400 Campus Drive

Worksite Address Line 2 -

Worksite City Somerset

Worksite State NEW JERSEY

Worksite Postal Code 8873

Job Title Senior Manager, Quality Systems

Minimum Education Master's

Other Degree/ Diploma -

Major Field of Study Pharmacy, Chemistry, or a related field

Required Training N

Required Training Month -

Required Field of Training -

Required Experience N

Required Expreience Months -

Accept Alternate Field of Study Y

Accept Alternate Major Pharmacy, Chemistry, or a related field

Alternate Combination of Education/ Experience Y

Required Alternate Level of Education Bachelor's

Other Alternate Level of Education -

Acceptable Years of Experience 5

Accept Foreign Educationa Y

Acceptable Alternate Occupation Y

Acceptable Alternate Occupation Month 24

Accept Alternate Job Title quality assurance

Normal Requirements of Job Opportunity N

Required Foreign Language N

Specific Skills Masters degree in Pharmacy, Chemistry, or a related field plus two years or Bachelors degree plus five progressive years of quality assurance experience. Must have at least two years of experience in each of the following 1. Defining quality control policies and control quality of pharmaceutical production operations; 2. Providing oversight to quality system elements to ensure compliance with regulatory expectations and pharmaceutical industry standards; 3. Writing, reviewing, and approving procedures SOPs, protocols, and reports pertaining to quality system elements affecting pharmaceutical product quality; 4. Conducting investigations of deviations, Out of Specification OOS, and complaints; 5. Coordinating the implementation of Corrective and Preventative Actions CAPAs for pharmaceutical laboratory and pharmaceutical production efforts; 6. Overseeing Change Control Systems for changes to systems, procedures, products, and processes for pharmaceutical manufacturing; and 7. Initiating and participating in continuous improvement initiatives for pharmaceutical production operations. Will accept any suitable combination of education, training, or experience.

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 2023-02-03

Job Oder End Date 2023-03-10

Sunday Edition Newspaper Y

First Newspaper Name The StarLedger

First Advertisement Start Date 2023-01-29

Second Newspaper Name The StarLedger

Second Advertisement Type Newspaper

Second Ad Start Date 2023-02-05

Job Fair From Date -

Job Fair to Date -

On Campus Recruiting from Date -

On Campus Recruiting to Date -

Employer Website from Date 2023-02-13

Employer Website to Date 2023-02-28

Pro. Org. Ad from Date -

Pro.Org. Ad to Date -

Job Search Website from Date -

Job Search Website to Date -

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 2023-02-01

Local Ethnic Newspaper to Date 2023-02-01

Radio/TV Ad from Date 2023-02-18

Radio/TV Ad to Date 2023-02-18

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 PHARMACY

Year of Compelted Education 2006

Foreign Worker Istitution of Eduation SARDAR PATEL UNIVERSITY

Foreign Worker Education Instution Address Line 1 MOTA BAZAAR, VALLABH VIDYANAGAR

Foreign Worker Education Institution Address Line 2 -

Foreign Worker Education Institution City GUJARAT

Foreign Worker Educatution Institution State -

Foreign Worker Education Institution Country INDIA

Foreign Worker Education Training Post Code 388120

Foreign Worker Training Completion N/A

Foreign Worker Required Experience N/A

Foreign Worker Alternate Education and Experience N/A

Foreign Worker Alternate Occupation Experience Y

Foreign Worker Experience with Employer N

Foreign Worker Employer Pay for Education N

Foreign Worker Currently Employed Y

Employer Completed Application N

Preparer Name Erin Hogan

Preparer Title Attorney

Preparer Email erin.hogan@quarles.com

Employer Information Declaration Name Prakash Salunke

Employer Declaration Title Director HR