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Laboratory Quality Assurance

2 months ago

Cincinnati, United States Medpace Full time

Responsibilities

Manage Internal and External Laboratory related Audits according to current applicable Regulations;

Coordinate, conduct and track company-wide Regulatory training and Quality Event Management;

Management and oversight of departmental Standard Operating Procedures, forms and templates;

Host Audits/Inspections by Sponsors and Regulatory Inspectors in a Clinical Lab setting;

Conduct vendor audits;

Coordinating, conducting, and tracking Regulatory Training (GLP and ICH/GCP) on a company wide basis;

Supervise QA Lab Auditors and Associates;

Assisting QA leadership with departmental overview and development of QA Auditors; and

Developing training materials and applicable tests and guides.

Qualifications

Bachelor’s degree in Life Sciences or a related field;

3 - 5 years of experience in a lab setting in a related industry required;

Knowledge and application of GCP and GLP is required;

Past supervisory experience is preferred;

Experience in conducting audits of vendors;

Experience in hosting Regulatory Authorities and interacting with Sponsor/client representatives;

Independent thinking and planning ability; and

Excellent written and verbal communication skills.

Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide 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 its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Today

The work we’ve done over the past 30 years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Medpace Celebrates 30 Years

As we celebrate 3 decades of industry expertise and organic growth, we recognize the global team responsible for driving clinical development at Medpace. Click here to learn more about Medpace Celebrating 30 Years.

Cincinnati Perks

Cincinnati Campus Overview

Hybrid work-from-home options (dependent upon position and level)

Competitive PTO packages, starting at 20+ days

Flexible work hours

Discounted tuition for UC online programs

Company-sponsored employee appreciation events

Employee health and wellness initiatives

Community involvement with local nonprofit organizations

Competitive compensation and benefits package

Structured career paths with opportunities for professional growth

Partnership and discount with onsite childcare

Discounts on local sports games, local fitness gyms and attractions

Official Sponsor of FC Cincinnati

Modern, ecofriendly campus with an on-site fitness center, bar, and restaurants

Awards:

Recognized by Forbes as one of America's Best Mid-size Companies in 2021 and 2022

Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next:

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

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