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. Essential daily job functions for this role include, but are not limited to:

• 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