Agent/ Attorney Address Line 1:8300 Greensboro Drive
Agent/ Attorney Address Line 2:Suite 550
Agent/ Attorney City:McLean
Agent/ Attorney State/ Province:VIRGINIA
Agent/ Attorney Country:UNITED STATES OF AMERICA
Agent/ Attorney Postal Code:22102
Agent/ Attorney Email:kvongsavanh@bal.com
Position Info
Prevailing Wage Track Number:P10020338936789
Prevailing Wage SOC Code :15-1121
Prevailing Wage SOC Title :Computer Systems Analysts
Prevailing Wage Skill Level:Level IV
Prevailing Wage:144414
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2021-05-07
Prevailing Wage Expiration Date :2021-08-05
Wage Offer From:172000
Wage Offer To:182000
Wage Offer Unit of Pay:Year
Workstie Address Line 1:5490 Great America Pkwy
Worksite Address Line 2:
Worksite City :Santa Clara
Worksite State:CALIFORNIA
Worksite Postal Code:95054
Job Title:Senior Quality Validation Manager
Minimum Education:Bachelor's
Other Degree/ Diploma:
Major Field of Study:See H.14
Required Training:N
Required Training Month:
Required Field of Training:
Required Experience :Y
Required Expreience Months :60
Accept Alternate Field of Study:Y
Accept Alternate Major:See H.14
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:SeeH.14
Normal Requirements of Job Opportunity:N
Required Foreign Language:N
Specific Skills:EMPLOYER WILL ACCEPT BACHELORS DEGREE IN CHEMISTRY, GENOMICS, MOLECULAR BIOLOGY, PHARMACYPHARMACEUTICAL ENGINEERING, COMPUTER SCIENCE, SOFTWARE ENGINEERING, OR RELATED FIELD, FOLLOWED BY FIVE YEARS OF PROGRESSIVE, POSTBACCALAUREATE WORK EXPERIENCE IN JOB OFFERED OR FIVE YEARS OF PROGRESSIVE, POSTBACCALAUREATE WORK EXPERIENCE IN A POSITIONRELATED OCCUPATION. POSITION REQUIRESbr br 5 YEARS OF EXPERIENCE LEADING VALIDATIONS OF VARIOUS TYPES OF SOFTWARE APPLICATIONS, INCLUDING WRITING AND REVIEWINGAPPROVING PROCESS DOCUMENTS SUCH AS SOPSWORK INSTRUCTIONS, COMPUTER VALIDATION DOCUMENTS IN A MEDICAL DEVICE, PHARMACEUTICAL, OR BIOLOGICS ENVIRONMENT IN THE AREAS OF QUALITY ASSURANCE, COMPLIANCE, INFORMATION TECHNOLOGY, AND MANUFACTURING; KNOWLEDGE OF FDA, EUROPEAN UNION, AND GXP REGULATORY REQUIREMENTS, INCLUDING 21 CFR PART 11ANNEX 11, ISO 1348514791, ICH Q9, FROM A GOVERNANCE, RISK, AND COMPLIANCE PERSPECTIVE. 5 YEARS; SDLC METHODOLOGIES, INCLUDING WATERFALL, VMODEL, AND, AGILE RISK BASED MODEL. 5 YEARS; VALIDATION EXPERIENCE WITH CONFIGURED OFFTHESHELF IN DIFFERENT ENVIRONMENTS SAAS, CLOUD HOSTED, AND ONPREMISE 5 YEARS; TECHNICAL EXPERIENCE IN INFRASTRUCTURE AND APPLICATIONS. 5 YEARS; EXPERIENCE IN IMPLEMENTATION AND CONTINUOUS IMPROVEMENT OF COMPUTER VALIDATION PROCESS ALIGNING WITH REGULATORY REQUIREMENTS AND INDUSTRY TRENDS; REGULATORY AND VENDOR AUDITS, QUALITY RISK MANAGEMENT TECHNIQUES AND TOOLS E.G. FMEA, SRA, ETC.; DATA GOVERNANCEINTEGRITYLIFE CYCLES AND MANAGEMENT; ORGANIZATIONAL, MANAGEMENT AND LEADERSHIP SKILLS; KNOWLEDGE AND EXPERIENCE IN QUALITY MANAGEMENT SYSTEMS E.G. CAPANCRDEVIATIONETC.; AND ABILITY TO TRAIN LARGE GROUPS ON COMPUTER VALIDATION PROCESSES.
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:2021-07-20
Job Oder End Date:2021-08-25
Sunday Edition Newspaper:Y
First Newspaper Name:Mercury News
First Advertisement Start Date:2021-07-25
Second Newspaper Name:Mercury News
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:2021-09-30
Employer Website to Date:2021-10-08
Pro. Org. Ad from Date:
Pro.Org. Ad to Date:
Job Search Website from Date:2021-07-19
Job Search Website to Date:2021-08-03
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:2021-07-30
Local Ethnic Newspaper to Date:2021-07-30
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:CHEMISTRY
Year of Compelted Education:2006
Foreign Worker Istitution of Eduation:EASTERN NEW MEXICO UNIVERSITY
Foreign Worker Education Instution Address Line 1:1500 S AVENUE K
Foreign Worker Education Institution Address Line 2:
