Job Title Quality Auditor /Clinical and Regulatory Analyst
Location Madison, New Jersey
Duration 6 Months
Qualifications:
REQUIRED
Education: Bachelor's degree with 5 years related experience
At least 2 years auditing experience in the regulatory compliance environment.
Knowledgeable in bioanalytic, pre/clinical research studies
Familiar with Analyst and Watson LIMS bioanalytical systems.
Excellent problem-solving skills.
PREFERRED:
Knowledge/familiarity of R&D
Working knowledge of FDA Guidance for Industry, Bioanalytical Method Validation (LC/MS-MS preferred).
Must have strong written, verbal and interpersonal communication skills. Excellent cross-functional team collaboration. The ability to work well and communicate well with others.
Must possess excellent organizational skills with the ability to perform and manage multiple tasks and manage to multiple tight deadlines without sacrificing quality.
Strong math skills, auditing skills, writing and communication skills.
Responsibilities:
The primary focus of this position is to ensure that planned and systematic processes are established and adhered to so that the study data is collected, documented, reported and is in compliance with GLPs, GCPs or other applicable regulatory requirements, in addition to, study protocols, SOPs, and industry guidance and standards.
MAJOR ACTIVITIES AND RESPONSIBILITIES
Review animal health bioanalytical studies conducted in-house. Be familiar with auditing GLP data in Analyst and Watson LIMS systems.
Review animal health pre-clinical and clinical study reports and data to ensure animal health drug safety and efficacy
Issues 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 have occurred. Distributes audits to management.
Assists in performing facility inspections of internal contract research organizations that are utilized for GCP and GLP studies or study support.
Issues audit reports and ensure resolution to observations.
Review and provide feedback on protocols and protocol amendments for compliance with SOPs, government regulations and guidelines and for internal consistency.
GLP/GCP and animal health audits
Due to current COVID policies and restrictions, this position will be remote. Once the restrictions are lifted, this may become a partially remote position in Madison, NJ. Candidates must be local.
This will start out as a 6 month role with a possible extension.
