Agent/ Attorney Address Line 1:135 S LaSalle Street
Agent/ Attorney Address Line 2:3425
Agent/ Attorney City:Chicago
Agent/ Attorney State/ Province:ILLINOIS
Agent/ Attorney Country:UNITED STATES OF AMERICA
Agent/ Attorney Postal Code:60603
Agent/ Attorney Email:jhoskin@zulkiepartners.com
Position Info
Prevailing Wage Track Number:P10020150612178
Prevailing Wage SOC Code :11-9199
Prevailing Wage SOC Title :Regulatory Affairs Managers
Prevailing Wage Skill Level:Level IV
Prevailing Wage:164694
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2020-11-03
Prevailing Wage Expiration Date :2021-06-30
Wage Offer From:165000
Wage Offer To:195800
Wage Offer Unit of Pay:Year
Workstie Address Line 1:125 Spring Street
Worksite Address Line 2:
Worksite City :Lexington
Worksite State:MASSACHUSETTS
Worksite Postal Code:2421
Job Title:Sr QA Specialist
Minimum Education:Master's
Other Degree/ Diploma:
Major Field of Study: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:60
Accept Alternate Job Title:QA Specialist or rltd pstn
Normal Requirements of Job Opportunity:N
Required Foreign Language:N
Specific Skills:WILL ACCEPT ANY LEVEL OF EXPERIENCE IN THE FOLLOWING SKILLS EXPERIENCE WITH BATCH RELEASE PROCESS AND EXCURSIONS GENERATED DURING GMP ACTIVITIES SUCH AS DEVIATIONS, NONCONFORMANCES NCR, OUT OF SPECIFICATION OOS INVESTIGATIONS AND CAPA; DIRECT EXPERIENCE IN PREPARING AND REVIEWING MATERIALS FOR DEVICE SUBMISSIONS TO REGULATORY AUTHORITIES I.E. FDA, EUROPEAN BODIES; EXPERIENCE IN LEADING, CONDUCTING, HOSTING MEDICAL DEVICE QUALITY SYSTEM AUDITS PER ISO 13485 AND 21 CFR 820 IN ADDITION TO MEDICAL DEVICE RISK ASSESSMENT PER ISO 14971 AND ASSOCIATED TOOLS FMEA, FMECA; WORKING KNOWLEDGE OF E.U., U.S. AND INTERNATIONAL DRUGS AND MEDICAL DEVICE REGULATIONS AND STANDARDS INCLUDING FDA 21 CODE OF FEDERAL REGULATIONS CFRS PART 820, 803, 211, 210, E.U. IVD AND MEDICAL DEVICE REGULATIONS, ISO 13485, ISO 14971.
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:2021-03-15
Job Oder End Date:2021-04-16
Sunday Edition Newspaper:Y
First Newspaper Name:The Boston Globe
First Advertisement Start Date:2021-03-14
Second Newspaper Name:The Boston Globe
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-03-21
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:2021-03-12
Employer Website to Date:2021-04-20
Pro. Org. Ad from Date:
Pro.Org. Ad to Date:
Job Search Website from Date:2021-03-14
Job Search Website to Date:2021-04-12
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:2021-03-18
Local Ethnic Newspaper to Date:2021-03-18
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:2015
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:Jennifer A Hoskin
Preparer Title:Associate
Preparer Email :jhoskin@zulkiepartners.com
Employer Information Declaration Name:Paul Lambert
