Clinical and Regulatory Analyst - II (Associate) in Madison, NJ at Integrated Resources, Inc

Date Posted: 4/14/2021

Job Snapshot

Job Description

REQUIRED Education: Bachelors 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.

**This is an Auditor role** The client Animal Health Division is looking for a **Quality Auditor** to provide Quality Assurance oversight to the Global Research and Development Department. This role will satisfy the requirements for a Quality Assurance Unit (QAU) according to the FDA 21 CFR Part 58 Good Laboratory Practice Regulations and the VICH GL9 Good Clinical Practice Guidance Document. 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 ensures 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 About you You are a motivated problem solver!! You are a meticulous, punctual, reliable and determined multi-tasker. You are extremely collaborative and encourage others to share ideas and input, however you also understand the importance of when and where to work independently. You work with integrity and fairness. You are extremely detail oriented and tend to see big picture. 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.