Hybrid R&D Quality Assurance Specialist
Apply NowCompany: OnBoard
Location: Rahway, NJ 07065
Description:
On-Board Scientific is hiring a Hybrid R&D Quality Assurance Specialist in Rahway, NJ
For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position Title and State you are located
About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.
Position Details:
Title: R&D Quality Assurance Specialist
Position Type: 8 month contract with additional opportunity contingent upon performance and continued business need
Job Location: Hybrid, in office, Rahway, NJ 3 days per week, remote 2 days per week
Shift: 1st shift
Compensation: $59- $63.50/HR
Responsibilities:
This position will provide Quality Assurance oversight to the 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 assure that planned and systematic processes are established to ensure that a study and the 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, EPA and 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
Reviewing Protocols, Protocol Amendments, Data and Reports for animal health GCP and GLP Studies including bioanalytical studies conducted in-house. Familiarity with auditing GLP data in Analyst and Watson LIMS systems is a plus.
Issues audit reports to the study monitor, study director, investigator, and study management as appropriate. Tracks audit reports. Review audit responses to ensure appropriate actions and documentation has occurred. Distributes audits to management.
Assist in performing internal facility inspections of Client Animal Health research facilities. Issue reports to department and management.
Qualifications:
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 or experience in reviewing GLP data
Experience working in a GLP environment
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:
GMP
IT QA
IT quality system
www.onboardusa.com
Apply Today!
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board's Mission is to provide "Flexible Service by applying the talents of our people, work processes and technology to meet our clients' expectations in a Safe, Responsible and Dependable manner."
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.
JD# 24-03771
Tag: INDOJ
For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position Title and State you are located
About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.
Position Details:
Title: R&D Quality Assurance Specialist
Position Type: 8 month contract with additional opportunity contingent upon performance and continued business need
Job Location: Hybrid, in office, Rahway, NJ 3 days per week, remote 2 days per week
Shift: 1st shift
Compensation: $59- $63.50/HR
Responsibilities:
This position will provide Quality Assurance oversight to the 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 assure that planned and systematic processes are established to ensure that a study and the 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, EPA and 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
Reviewing Protocols, Protocol Amendments, Data and Reports for animal health GCP and GLP Studies including bioanalytical studies conducted in-house. Familiarity with auditing GLP data in Analyst and Watson LIMS systems is a plus.
Issues audit reports to the study monitor, study director, investigator, and study management as appropriate. Tracks audit reports. Review audit responses to ensure appropriate actions and documentation has occurred. Distributes audits to management.
Assist in performing internal facility inspections of Client Animal Health research facilities. Issue reports to department and management.
Qualifications:
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 or experience in reviewing GLP data
Experience working in a GLP environment
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:
GMP
IT QA
IT quality system
www.onboardusa.com
Apply Today!
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board's Mission is to provide "Flexible Service by applying the talents of our people, work processes and technology to meet our clients' expectations in a Safe, Responsible and Dependable manner."
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.
JD# 24-03771
Tag: INDOJ