Quality Assurance Auditor

About the role

As a Quality Assurance Auditor, you will work with the QA team to perform analytical-based auditing activities as necessary and implement auditing systems to ensure compliance with GLP requirements. You will apply regulatory interpretation to a wide variety of work situations of increasing difficulty to most work situations.

Responsibilities

• Performs audits of study-based protocols, plans, in-process activities, data, test methods, and a variety of reports and issues inspection and audit reports
• Reports compliance deficiencies to the QA Director and recommended actions to conform to SOP and regulatory standards
• Works laterally with scientific staff to assure the facility and operations meets standards set by Veloxity Labs procedures and FDA regulations
• Assists with development and/or reviews SOPs, Technical Procedures, Qualification Plans, and Validation Plans
• Attends managerial and/or staff meetings
• Develop, revise review and implement SOPs and Technical Procedures as applicable to the position
• Conduct archiving processes

Education and Experience

An undergraduate degree or higher, preferably in a science related field or equivalent experience. Ideally have quality control or quality assurance and/or regulatory work experience, but it is not necessary (you will be trained at Veloxity Labs). Working knowledge of MS Office suite (emphasis in Word and Excel). Ideally have knowledge of bioanalytical laboratory equipment, assays, techniques is preferred. Ideally have a working knowledge of FDA Good Laboratory Practices (GLPs) and other FDA regulatory guidance’s is not required (you will be trained at Veloxity Labs).

Desired Skills and Abilities

• High level of attention to detail
• The ability to utilize appropriate mathematical concepts for interpreting scientific data
• Ability to read protocols, possess good writing and good oral communication skills
• Skill in written and verbal communication
• Ability to interpret and apply agency regulations and guidelines
• Ability to communicate with other employees in order to develop sound procedures and policies
• May attend SQA meetings or participate in webinars or on-line training resources to further continuing education