Previous State Work Force Agency (SWA) Case Number Stete:
Schedule A or a Sheepherder Occupation :N
Company Info
Employer Name:TAKEDA DEVELOPMENT CENTER AMERICAS, INC.
Employer Address_Line 1:95 HAYDEN AVE
Employer Address_Line 2:
Employer City :LEXINGTON
State:
Employer State/ Province:MASSACHUSETTS
Employer Country:UNITED STATES OF AMERICA
Employer Postal Code:2421
Employer Phone No.:224-544-1749
Employer Phone Extent No.:
Total Number of Employees:18000
Employer Year of Commenced :
NAICS Code:325411
Foreign Worker Ownership & Interest:N
HR Info
Employer Contact Name:Paul Lambert
Employer Contact Address Line1:95 Hayden Ave
Employer Contact Address Line2:
Employer Contact City:Lexington
Employer Contact State/ Provice:MASSACHUSETTS
Employer Contact Country :UNITED STATES OF AMERICA
Employer Contact Post Code:2421
Employer Contact Phone:224-544-1749
Employer Contact Email:paul.lambert@takeda.com
Attorney
Agent/ Attorney Name:Susan M MacLean
Agent/ Attorney Firm Name:Zulkie Partners LLC
Agent/ Attorney Phone:(312) 831-2129
Agent/ Attorney Phone Ext.:
Agent/ Attorney Address Line 1:135 S. La Salle Street
Agent/ Attorney Address Line 2:Suite 3425
Agent/ Attorney City:Chicago
Agent/ Attorney State/ Province:ILLINOIS
Agent/ Attorney Country:UNITED STATES OF AMERICA
Agent/ Attorney Postal Code:0
Agent/ Attorney Email:smaclean@zulkiepartners.com
Position Info
Prevailing Wage Track Number:P10021039062187
Prevailing Wage SOC Code :13-1041
Prevailing Wage SOC Title :Regulatory Affairs Specialist
Prevailing Wage Skill Level:Level IV
Prevailing Wage:100880
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2021-06-25
Prevailing Wage Expiration Date :2021-09-23
Wage Offer From:101000
Wage Offer To:157300
Wage Offer Unit of Pay:Year
Workstie Address Line 1:35 Landsdowne Street
Worksite Address Line 2:
Worksite City :Cambridge
Worksite State:MASSACHUSETTS
Worksite Postal Code:2139
Job Title:Good Manufacturing Practice Quality Program Manager
Minimum Education:Bachelor's
Other Degree/ Diploma:
Major Field of Study:Chemistry, Biology, Engineering, Regulatory Affairs or related field
Required Training:N
Required Training Month:
Required Field of Training:
Required Experience :N
Required Expreience Months :
Accept Alternate Field of Study:N
Accept Alternate Major:
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:Y
Acceptable Alternate Occupation Month:72
Accept Alternate Job Title:Quality Assurance Supervisor or related occupation
Normal Requirements of Job Opportunity:N
Required Foreign Language:N
Specific Skills:Prior experience must include at least 6 years of experience with each of the following Oversee and conduct final release and product disposition of Commercial and Clinical Trial GMP Material Drugs, Biologics, Small molecule etc. for use per Code of Federal Regulations 21CFR, ICH and other regulatory agency requirements; independently perform Root Cause Analysis and write, review and lead deviation investigations, Change controls, CAPA, nonconformance, Complaints and related technical quality system documentation for compliance to regulatory requirements; provide quality and compliance support by conducting and supporting QualityRegulatory audits, generating Quality Agreements, coordinating with QPs for product release and participating in CMCCMO meetings to ensure product development per cGMP needs; review and approve analytical test method protocols, Scaleup Process Validation reports, Master Executed Batch Records, Test Specifications and Stability studies reports.
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:2021-07-23
Job Oder End Date:2021-08-23
Sunday Edition Newspaper:Y
First Newspaper Name:The Boston Globe
First Advertisement Start Date:2021-07-25
Second Newspaper Name:The Boston Globe
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-08-01
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:2021-07-23
Employer Website to Date:2021-08-23
Pro. Org. Ad from Date:
Pro.Org. Ad to Date:
Job Search Website from Date:2021-07-25
Job Search Website to Date:2021-08-23
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:2021-07-29
Local Ethnic Newspaper to Date:2021-07-29
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: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 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:2115
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:Susan M MacLean
Preparer Title:Attorney
Preparer Email :smaclean@zulkiepartners.com
Employer Information Declaration Name:Paul Lambert
