Quality Assurance coordinator Global R&D
Apply NowCompany: AA2IT
Location: Rahway, NJ 07065
Description:
Title: Quality Assurance coordinator Global R&D
Pay Rate: $60/HR
Location: 126 E. Lincoln Avenue, Rahway, NJ 07065
Qualifications:
Actual Job Title: Quality Assurance coordinator Global R&D Q A (Contractor)
Education: Bachelor's degree with at least 2 years GLP auditing experience in the R & D regulatory compliance environment or 3 years related experience.
Must haves:
QA R&D auditing or experience in reviewing R&D data
Experience in a GLP Environment
Experience in managing department SOPs
Animal Health Clinical Auditing a plus
Must have strong communication, organization and writing skills.
Ability to perform in a multi-task environment.
Software:
MS office suite
My learning experience.
Not looking for auditing experience in:
GMP
IT QA
IT quality system
Note:
Hybrid 3 days onsite (Tuesday and Weds onsite core days, choice of Monday or Thursday for third onsite day)
Work location: Rahway, NJ
Responsibilities:
Briefly summarize the primary purpose of the position.
This position will provide Quality Assurance oversight to Intervet Inc. (d/b/a Client Animal Health) Global Research and Development Department. It will satisfy the requirements for a Quality Assurance Unit (QAU) according to the FDA 21 CFR Part 58 Good Laboratory Practice Regulations (GLPs) and the VICH GL9 Good Clinical Practice Guidance Document (GCPs).
The primary focus of this position is to act as a Quality Assurance coordinator to assist in the following tasks:
Managing the QA SOPs
Managing QA training documentation
Coordinating Auditor schedules for CRO and Internal Inspections
Archival of QA documentation
QA metrics
Creating and distributing the list of outstanding QA audit reports
This position will also assist in assuring that planned and systematic processes are established to ensure that the study data are collected, documented, and reported are in compliance with the GLPs and GCPs or other applicable regulatory requirements, as well as study protocols, SOPs, and industry guidance and standards.
This position is key to the completion of final study reports for GCP and GLP studies required for submission to CVM, USDA or international regulatory agencies. A thorough and expeditious audit process is necessary for meeting high-quality submission requirements.
This position is required in assuring our company research meets or exceeds all relevant government and company compliance regulations and standards.
Major activities and responsibilities include:
Assist in:
QA SOP management
QA training documentation management
Coordination of schedules for CRO and Internal Inspections
Archival of QA documentation
QA metrics
Creating and distributing the list of outstanding QA audit reports
Assist in performing internal facility inspections of Client Animal Health research facilities.
Assist in:
Auditing GLP or GCP regulated studies:
Protocols/ Protocol Amendments
Study Data
Stat Reports
Final Study Report
Issue audit reports to the study monitor, study director, investigator, and study management as appropriate. Tracks audit reports. Reviews audit responses to ensure appropriate actions and documentation has occurred. Distributes audits to management.
Kindly share your resume with answers:
Q1: How many years of exp in GLP auditing experience in the R & D regulatory compliance environment
Q2: Any exp in Animal Health Clinical Auditing
Q3: how many years of exp Managing the QA SOPs
Q4: How many years of exp in Auditing GLP or GCP regulated studies Protocols/ Protocol Amendments !
Q5: how far you live from 126 E. Lincoln Avenue, Rahway, NJ 07065 and are you good with Hybrid working (3 days office )
Pay Rate: $60/HR
Location: 126 E. Lincoln Avenue, Rahway, NJ 07065
Qualifications:
Actual Job Title: Quality Assurance coordinator Global R&D Q A (Contractor)
Education: Bachelor's degree with at least 2 years GLP auditing experience in the R & D regulatory compliance environment or 3 years related experience.
Must haves:
QA R&D auditing or experience in reviewing R&D data
Experience in a GLP Environment
Experience in managing department SOPs
Animal Health Clinical Auditing a plus
Must have strong communication, organization and writing skills.
Ability to perform in a multi-task environment.
Software:
MS office suite
My learning experience.
Not looking for auditing experience in:
GMP
IT QA
IT quality system
Note:
Hybrid 3 days onsite (Tuesday and Weds onsite core days, choice of Monday or Thursday for third onsite day)
Work location: Rahway, NJ
Responsibilities:
Briefly summarize the primary purpose of the position.
This position will provide Quality Assurance oversight to Intervet Inc. (d/b/a Client Animal Health) Global Research and Development Department. It will satisfy the requirements for a Quality Assurance Unit (QAU) according to the FDA 21 CFR Part 58 Good Laboratory Practice Regulations (GLPs) and the VICH GL9 Good Clinical Practice Guidance Document (GCPs).
The primary focus of this position is to act as a Quality Assurance coordinator to assist in the following tasks:
Managing the QA SOPs
Managing QA training documentation
Coordinating Auditor schedules for CRO and Internal Inspections
Archival of QA documentation
QA metrics
Creating and distributing the list of outstanding QA audit reports
This position will also assist in assuring that planned and systematic processes are established to ensure that the study data are collected, documented, and reported are in compliance with the GLPs and GCPs or other applicable regulatory requirements, as well as study protocols, SOPs, and industry guidance and standards.
This position is key to the completion of final study reports for GCP and GLP studies required for submission to CVM, USDA or international regulatory agencies. A thorough and expeditious audit process is necessary for meeting high-quality submission requirements.
This position is required in assuring our company research meets or exceeds all relevant government and company compliance regulations and standards.
Major activities and responsibilities include:
Assist in:
QA SOP management
QA training documentation management
Coordination of schedules for CRO and Internal Inspections
Archival of QA documentation
QA metrics
Creating and distributing the list of outstanding QA audit reports
Assist in performing internal facility inspections of Client Animal Health research facilities.
Assist in:
Auditing GLP or GCP regulated studies:
Protocols/ Protocol Amendments
Study Data
Stat Reports
Final Study Report
Issue audit reports to the study monitor, study director, investigator, and study management as appropriate. Tracks audit reports. Reviews audit responses to ensure appropriate actions and documentation has occurred. Distributes audits to management.
Kindly share your resume with answers:
Q1: How many years of exp in GLP auditing experience in the R & D regulatory compliance environment
Q2: Any exp in Animal Health Clinical Auditing
Q3: how many years of exp Managing the QA SOPs
Q4: How many years of exp in Auditing GLP or GCP regulated studies Protocols/ Protocol Amendments !
Q5: how far you live from 126 E. Lincoln Avenue, Rahway, NJ 07065 and are you good with Hybrid working (3 days office )