Specific Skills:Must have at least 1 year of prior work experience in each of the following 1.Working with quality system requirements including U.S. FDA GMP, EMA, and ICH guidelines. 2.Applying quality engineering principles including, Design of Experiment, structured problem solving, and root cause investigations. 3.Participating in regulatory inspections to ensure compliance. 4.Performing and reviewing pharmaceutical investigations including deviations, nonconformances, and supplier investigations using electronic systems such as TrackWise. 5.Conducting root cause analyses and identifying Corrective and Preventive Actions using Quality System management processes to prevent recurrences of quality issues in the manufacturing area. 6.Reviewing change controls and supplier batch records to ensure compliance with internal and regulatory requirements. 7.Driving continuous improvement using quality tools such as lean, six sigma, and risk management. 8.Executing statistical data analysis using Minitab or JMP statistical analysis software. 9.Managing and providing oversight of quality system records such as deviations, CAPA, change controls, supplier investigation, and corrective actions request using TrackWise.br br Position requires 25 travel. Position allows telecommuting, applicant may reside anywhere in U.S. and report to South San Francisco, CA. Any incurred business travel will be fully reimbursed.br br Experience must be progressively responsible and postbaccalaureate.
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:2022-12-23
Job Oder End Date:2023-01-26
Sunday Edition Newspaper:Y
First Newspaper Name:San Francisco Chronicle
First Advertisement Start Date:2023-01-08
Second Newspaper Name:San Francisco Chronicle
Second Advertisement Type:Newspaper
Second Ad Start Date:2023-01-15
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:
Employer Website to Date:
Pro. Org. Ad from Date:2023-01-06
Pro.Org. Ad to Date:2023-01-20
Job Search Website from Date:2023-01-06
Job Search Website to Date:2023-01-20
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:2023-01-11
Local Ethnic Newspaper to Date:2023-01-11
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:PHARMACEUTICAL MANUFACTURING
Year of Compelted Education:2009
Foreign Worker Istitution of Eduation:STEVENS INSTITUTE OF TECHNOLOGY
Foreign Worker Education Instution Address Line 1:CASTLE POINT TERRACE
Foreign Worker Education Institution Address Line 2:
Foreign Worker Education Institution City:HOBOKEN
Foreign Worker Educatution Institution State:NJ
Foreign Worker Education Institution Country :UNITED STATES OF AMERICA
Foreign Worker Education Training Post Code:7030
Foreign Worker Training Completion :N/A
Foreign Worker Required Experience :N/A
Foreign Worker Alternate Education and Experience :N/A