Regulatory and Quality Assurance Associate I

Pegus Research Inc; Salt Lake City (UT); Hybrid; USD 24,000 - 28,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with match

HSA contribution

Paid holidays

Paid time off

Work from home flexibility

Job summary

PEGUS Research in Salt Lake City is seeking a Regulatory Affairs and Quality Assurance Associate I. This entry-level, full-time role supports the RAQA team with document reviews, regulatory compliance, and audits preparation.

You will learn FDA regulations, GCP guidelines, and Good Documentation Practices while contributing to studies. Starting pay is $17.50–$20.00 per hour, with a typical 40-hour week, benefits including medical, dental, and vision insurance, a 401(k) match, HSA, holidays, and

Qualifications

• Strong written and verbal communication skills with a can-do attitude.
• Knowledge of computer systems for document creation and collaboration.
• Organized, detail oriented, and quick to learn with process improvement focus.
• Ability to work independently with initiative and good interpersonal skills.
• Knowledge of Good Documentation Practices is a plus.

Responsibilities

• Review, file, and organize essential study documentation in the Trial Master File.
• Ensure documentation follows FDA and other regulations.
• Assist in identifying and addressing non-compliance causes.
• Help prepare studies for audits and annual SOP reviews.
• Prepare documents for IRB submission and archiving.

Skills

Written and verbal communication

MS Office

Adobe Acrobat

Organized

Attention to detail

Interpersonal skills

Self-motivation

Tools

MS Office

Adobe Acrobat

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Regulatory and Quality Assurance Associate I

Full-Time Hourly Individual Contrib PEGUS Research - SLC, Salt Lake City, UT, US 1 Attachments

2 days ago Requisition ID: 1183

Salary Range: $17.50 To $20.00 Hourly

Regulatory Affairs and Quality Assurance Associate I - PEGUS Research - Salt Lake City, UT

PEGUS Research is looking for a detail-oriented and motivated self-starter to join our Regulatory Affairs and Quality Assurance (RAQA) team. Our research broadens consumer healthcare choices and has a positive impact on public health. Joining our team lets you contribute to this unique mission. This is also a great opportunity for an early career professional to gain research experience and expand their skills.

The PEGUS Research RAQA team reviews and submits key study documents to ethics boards, ensures studies are conducted in compliance with FDA regulations, Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements and standards including ethical conduct. The RAQA Associate I directly contributes to the team in these ways:

• Reviews, files, and organizes essential study documentation in the Trial Master File.
• Ensures documentation follows FDA and other regulations
• Assists in the work of identifying, addressing, and eliminating causes of non-compliance
• Assists in preparing studies for audits
• Assists in the annual review of company Standard Operating Procedures
• Prepares documents for submission to the IRB (ethics review board)
• Prepare study documents for archiving and storage

Qualifications:

• Strong written and verbal communication skills, with a can-do attitude
• Knowledge of computer systems for document creation and collaboration, especially MS Office and Adobe Acrobat.
• Organized, detail oriented, and ability to learn quickly with a desire to improve and enhance processes
• Strong work ethic, with the ability to take initiative and work independently as needed
• Attention to detail, and good interpersonal skills
• Knowledge of Good Documentation Practices, a plus.

Salary and Benefits:

• Starting Pay: $17.50 - $20.00 hourly (based on education, experience and fit)
• Approximately 40 hours per week, during regular business hours (M-F, 9-5)
• Medical, dental, vision, life and disability insurance, up to 4% match on our 401(k) plan and HSA contribution
• 13 paid holidays and paid time off equivalent to 13 days per year
• Mostly flexible work environment with the ability to work from your home, as assigned
• Growth potential and skill building opportunities
• A great team environment: we work hard and have fun doing it!

If you have these qualifications, and want to work for a unique company

that has an impact on public health and consumer choice,

To learn more about PEGUS, our team and our research studies, visit www.pegus.com.