R&D Quality Assurance Auditor

Your Role: R&D Quality Assurance Auditor

This role provides quality oversight and consultative support our client in the animal pharmaceutical space, serving as the GLP Test Facility Quality Assurance Unit to ensure regulatory compliance for non-clinical safety studies. Based at the Fort Dodge site, the position oversees regulated activities including VICH GL9 standards to support global product approvals for veterinary medicines. By partnering closely with R&D stakeholders, the role proactively drives compliance through the implementation of our client's Quality Standards, specialized training, and strategic quality input.

Location: Fort Dodge, Iowa (On-site Position)

• The Fort Dodge site is looking to expand its GLP operations and requires a Quality Assurance Auditor to be present onsite in order to be compliant with FDA regulations. This person will be responsible for ensuring regulatory compliance for non-clinical safety studies and must be present for all FDA audit.

Schedule: Monday-Friday (On-site)

Pay: $65-75/hr ($125-155k/salary)

Your Responsibilities:

• Regulatory Execution & Leadership: Execute the site Quality Assurance program in strict compliance with FDA GLP (21 CFR Part 58) and vGCP (VICH GL9) standards, while serving as the ERDQA representative to the R&D Site Lead Team.
• Comprehensive Auditing: Plan and conduct end-to-end internal and third-party audits—including protocol, in-life, data, and final report reviews—to ensure total adherence to regulatory requirements.
• Sponsor & System Oversight: Provide critical Sponsor oversight for non-clinical safety and clinical studies conducted at third parties, while maintaining quality standards for R&D GXP equipment, systems, and site procedures.
• Quality Management & CAPA: Manage the Quality Management System (QMS) by authoring site Quality procedures, leading investigations into deviations, and overseeing the implementation and suitability of Corrective and Preventive Actions (CAPA).
• Stakeholder Engagement & Training: Act as a primary liaison for regulatory authority inspections and external stakeholders, while developing and delivering compliance training to R&D and ERDQA teams to foster a culture of quality.

What You Need to Succeed (minimum qualifications):

• Education: Bachelor's of Science Degree in biology, animal science, pharmacy, or a related field.
• Experience: At least 10 years of experience in a quality oversight or monitoring role for veterinary clinical and safety studies (FDA, USDA, EPA regulated).
• Skills: Deep knowledge of GLP/GCP regulations, proven ability to influence senior scientific leaders, and a strong understanding of risk management and Quality Systems.

What Will Give You the Competitive Edge (preferred qualifications):

• Master’s in Life Sciences or a Doctor of Veterinary Medicine.
• Society for Quality Assurance RQAP-GLP certification.
• Experience with IACUC, Biosafety Committees, and Health and Safety protocols.

Why Join Us?

• 401(k) Matching Plan

• Medical, Dental, & Vision Plans

• Relationship Driven Process to Find Your Best Fit

• 6 Paid Holidays

• Regular Meetings to Ensure Quality in Your Engagement

How to Apply:

(Straightforward, easy one-click apply.)

EEO Statement:

Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and Ordinances.

Benefits & Perks:

Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays.

Pay Disclaimer:

The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.