In Vivo Quality Consultant

3 weeks ago


San Diego, United States CareerBuilder Full time

Medix is currently hiring for a Quality Consultant to join a pre-clinical CRO that we partner with in San Diego, CA. This is a hybrid position that offers part-time hours (approximately 20-25 hours per week).
The Quality Consultant will play a critical role in ensuring our business processes meet regulatory requirements, quality standards and align with safety standards. The Consultant drives change and ensures GLP compliance across the enterprise. The individual in this role is a multi-department collaborator and a in vivo study expert with strong attention to detail.
Essential Functions
Leading all pre-clinical GLP audits and study monitoring activities to ensure all are performed effectively and in a timely manner.
Provide GLP/QA leadership and thought partnership for client audits and regulatory inspections.
Liaise effectively with clients and collaborators to provide compliance advice and consultancy.
Identify and communicate business and regulatory changes that could impact on GLP compliance.
Ensure compliance with all guidelines for regulatory standards, as well as company policies/procedures.
Lead improvement processes linked to business needs.
Oversight of GLP archiving in the New Haven Clinic and maintains pre-clinical quality database for quality analysis and assessment and identifies compliance risk.
Other duties as assigned.
Qualifications
Bachelors Degree or equivalent work experience.
Significant relevant GLP experience (minimum 5 years) working with pre-clinical, in vivo studies.
Ability to work onsite or hybrid in San Diego.

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