Laboratory Quality Assurance (QA) Manager - Medpace, Inc.
Cincinnati, OH
About the Job
Laboratory Quality Assurance (QA) Manager
Job Locations
United States-OH-Cincinnati
Category
Quality Assurance
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 Us 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.
Cincinnati Perks
Cincinnati Campus Overview
Hybrid work-from-home options (dependent upon 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, ecofriendly 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 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.
EO/AA Employer M/F/Disability/Vets
Job Locations
United States-OH-Cincinnati
Category
Quality Assurance
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 Us 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.
Cincinnati Perks
Cincinnati Campus Overview
Hybrid work-from-home options (dependent upon 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, ecofriendly 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 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.
EO/AA Employer M/F/Disability/Vets
Source : Medpace, Inc.