Quality Assurance Auditor

Veloxity Labs; Peoria (IL); On-site; USD 65,000 - 85,000; Full time

Job summary

Veloxity Labs seeks a Quality Assurance Auditor to join the QA team. You will perform analytical auditing to ensure GLP compliance and apply regulatory interpretation to varied work situations.

You will audit study protocols, data, reports and test methods; report deficiencies to the QA Director; collaborate with scientists; help develop SOPs and procedures, and participate in archiving.

Qualifications

• Bachelor's degree in science or equivalent experience.
• Experience in quality assurance or regulatory work preferred but not required (training provided).
• Working knowledge of MS Office (Word and Excel).
• Knowledge of FDA GLP or related guidelines is beneficial but not required.

Responsibilities

• Performs audits of study-based protocols, plans, data, test methods, and reports.
• Reports compliance deficiencies to the QA Director and proposed actions.
• Works with scientific staff to ensure facility operations meet Veloxity Labs and FDA standards.
• Assists with development/reviews SOPs, Technical Procedures, Qualification Plans, and Validation Plans.
• Attends managerial or staff meetings and conducts archiving processes.

Skills

Attention to detail

Written communication

Verbal communication

Regulatory interpretation

Education

Bachelor's degree in science

Tools

MS Office (Word, Excel)

Job description

As a Quality Assurance Auditor, you willwork 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