Accept Alternate Major:Biotech.,Bio.Eng.,Med.Tech.,Biology, Chem., Eng., Bus., or a rel. field
Alternate Combination of Education/ Experience:Y
Required Alternate Level of Education :Master's
Other Alternate Level of Education:
Acceptable Years of Experience:4
Accept Foreign Educationa:Y
Acceptable Alternate Occupation:Y
Acceptable Alternate Occupation Month:60
Accept Alternate Job Title:Any in which the required experience is gained.
Normal Requirements of Job Opportunity:Y
Required Foreign Language:N
Specific Skills:Must have a Bachelors degree in Pharmacy, Biotechnology, Bioengineering, Medical Technology, Biology, Chemistry, Engineering, Business or a related field and 5 years of progressive, postbaccalaureate related work experience. Alternatively, will accept a Masters degree in Pharmacy, Biotechnology, Bioengineering, Medical Technology, Biology, Chemistry, Engineering, Business or a related field and 4 years of related work experience.br br Must have 4 years of experience in delivering advisory or consulting services to Life Sciences clients, or in compliance within the Life Sciences industry.br br Must have 3 years of quality management system QMS experience working with applicable regulatory requirements including 21 CFR Parts 11, 210, 211, 610, and 820, andor HIPAA.br br Must have 3 years of experience in project management, including accountability for schedules, deliverables, priorities and dependencies, progress updates, team management, and client service.br br Must have 2 years of experience in one or more of the followingbr br Quality and regulatory operations, developing, improving or remediating Quality management systems for Life Sciences organizations, performing or managing responses to health authority e.g. FDA observations, and implementing LIMS and other QMS systems.br Developing cGxP audit plans, assessments and reports. Assessing, designing and implementing audit, risk management andor compliance programs including risk governance, risk appetite and tolerance, riskbased strategicbusiness planning processes, and integration of risk management functions.br Designing continuous process improvement frameworks, tools and templates, conducting root cause assessment, and defining corrective and preventative actions CAPA in GxP environment.br Computerized System Validation CSV and testing in a validated environment, with handson experience with SDLC requirements, Agile or Waterfall methodologies, testing automation Quality Center andor ValGenesis, and tracking issues using JIRA.br Endtoend management of clinical trials including study design; study coordination; patient data acquisition and management; close out; external data management; regulatory reporting; and riskbased monitoring.br br Requires travel up to 80, to serve client needs.br br Employer 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:2021-05-18
Job Oder End Date:2021-06-22
Sunday Edition Newspaper:Y
First Newspaper Name:THE STARLEDGER
First Advertisement Start Date:2021-05-23
Second Newspaper Name:THE STARLEDGER
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-05-30
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:2021-05-18
Employer Website to Date:2021-06-22
Pro. Org. Ad from Date:
Pro.Org. Ad to Date:
Job Search Website from Date:2021-05-19
Job Search Website to Date:2021-06-22
Private Employment Firm from Date:
Pricate Employment Firm to Date:
Employee Referral Program from Date:2021-05-18
Employee Referral Program to Date:2021-06-22
Campus Placement from Date:
Campus Placement to Date:
Local Ethnic Newspaper from Date:
Local Ethnic Newspaper to Date:
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:BIOMEDICAL ENGINEERING
Year of Compelted Education:2016
Foreign Worker Istitution of Eduation:THE UNIVERSITY OF TEXAS AT DALLAS
Foreign Worker Education Instution Address Line 1:800 W CAMPBELL RD
Foreign Worker Education Institution Address Line 2:
