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Laboratory Quality Assurance (Qa) Auditor

0-2 years
Not Disclosed
10 Oct. 23, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Summary

The QA Auditor will be responsible for conducting both internal and external audits, as well as coordinating, tracking, and conducting company-wide Regulatory Training, CAPA Investigations, and Metric Analysis. This role ensures compliance with Standard Operating Procedures (SOPs), current regulations, and standards. Additionally, the Auditor will assist in the creation and maintenance of controlled documents. Given the visibility of this position to both internal and external clients, strong communication skills, proactive enthusiasm, and critical thinking are essential.

Responsibilities

  • Conduct internal and external laboratory-related audits in accordance with current applicable regulations.
  • Track company-wide regulatory training, CAPA investigations, and metrics analysis.
  • Ensure compliance with Standard Operating Procedures, regulations, and standards.
  • Assist in the creation and maintenance of controlled documents.
  • Interact effectively with internal and external clients.

Qualifications

  • Bachelor’s degree in a science or related field.
  • Experience in quality assurance or laboratory settings is a plus.
  • Excellent written and verbal communication skills.
  • Strong attention to detail and well-organized.
  • Ability to work well in a team environment as well as independently.

About Medpace

Medpace is a full-service clinical contract research organization (CRO) that provides Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ over 5,000 people across more than 40 countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

Over the past 30+ years, our work has positively impacted the lives of countless patients and families facing various diseases. The efforts we make today will improve the lives of those living with illness in the future.

Cincinnati Perks

  • Hybrid work-from-home options (dependent on position and level)
  • Competitive PTO packages, starting at 20+ days
  • Competitive compensation and benefits package
  • Flexible work schedule
  • Company-sponsored employee appreciation events
  • Employee health and wellness initiatives
  • Community involvement with local nonprofit organizations
  • Discounts on local sports games, fitness gyms, and attractions
  • Modern, eco-friendly campus with an on-site fitness center
  • Structured career paths with opportunities for professional growth
  • Discounted tuition for UC online programs

Awards

  • Named a Top Workplace in 2024 by The Cincinnati Enquirer
  • Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024
  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine for expertise, quality, capabilities, reliability, and compatibility.