QUALITY SPECIALIST II (QA AUDITING – ANIMAL HEALTH) @ NEWAGE CLINICAL
We are seeking a highly skilled Quality Specialist II to join a major pharmaceutical team in Rahway, New Jersey, for a 21-month W2 contract. This role is dedicated to Global R&D Quality Assurance, specifically focusing on Animal Health GCP and GLP auditing. The successful candidate will conduct comprehensive audits of clinical and non-clinical studies, facilities, data, and reports to ensure strict adherence to regulatory standards.
The position requires oversight of Laboratory Information Management Systems (LIMS) and Electronic Data Capture (EDC) systems. Responsibilities include supporting regulatory inspections from bodies like the FDA, EPA, and OECD, as well as conducting thorough SOP reviews. Please note that this is a research-focused QA auditing role and does not involve GMP/GXP manufacturing.
The position requires oversight of Laboratory Information Management Systems (LIMS) and Electronic Data Capture (EDC) systems. Responsibilities include supporting regulatory inspections from bodies like the FDA, EPA, and OECD, as well as conducting thorough SOP reviews. Please note that this is a research-focused QA auditing role and does not involve GMP/GXP manufacturing.
Key Requirements
Bachelor’s degree in a relevant scientific field.
Minimum of 5 years of professional experience in the pharmaceutical or life sciences industry.
At least 2 years of direct regulatory auditing experience.
In-depth knowledge of Animal Health GCP (VICH GCP) for clinical studies.
Strong expertise in Animal Health GLP for non-clinical studies.
Proficiency in auditing studies, facilities, raw data, and final reports.
Experience with Laboratory Information Management Systems (LIMS) review.
Familiarity with Electronic Data Capture (EDC) clinical data systems review.
Ability to support regulatory inspections by agencies such as the FDA, EPA, or OECD.
Skilled in Standard Operating Procedure (SOP) review and compliance oversight.
Excellent documentation and comprehensive audit reporting skills.