QC Specialist - Bioanalytical Laboratory
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 approximately 3,500 people across almost 40 countries.
Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based QC Specialist to join our Bioanalytical Lab team. This position will work on a team to accomplish tasks and projects that are instrumental to the company's success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.
Review all studies conducted according to Good Laboratory Practice (GLP) performed by assigned Study Director (SD) or Principle Investigator (PI)
Review, document, and report all raw data, experimental procedures, documents and results to meet regulatory requirements
Conduct QC review of departmental log books, equipment and instrument logs, equipment and software installation (IQOQPQ) and validation documents, solution-reagent labels, reference standards, and controlled substances inventories
Assist and work with the SD or PI to ensure completion of the study to meet client timelines and quality needs
Support Regulatory Authority Inspections and Sponsor Audits at MBL (i.e., procurement, retrieval, review, or provision of raw study data as directed by the SD or PI or Medpace QA department)
Assist SD or PI to ensure compliance to SOPs, suggest SOP revisions when applicable, ensure reported and/or identified deviations to SOPs are properly documented in Study Report
Bachelor's degree required and 1 year of closely-related regulated (GLP) industry experience (quality control experience is preferred);
Demonstrate basic computer literacy, efficiently use Microsoft Office software, and conduct internet reference searches;
Ability to complete, properly document, report to management, and ensure resolution of all assigned QC reviews of each project efficiently, correctly, and within specified timeframes;
Demonstrate effective communication (written and verbal) skills;
Understand regulations applicable to Medpace lines of business (i.e., GCP, ICH, GLP, OECD);
Demonstrate working knowledge of Medpace (and Sponsor provided where applicable) SOPs and policies; and
Fundamental knowledge of bioanalytical terminology.
When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.
Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
Recognized by Forbes as one of America's Best Mid-size Companies in 2021
Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next:
A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.
*WARNING:Please beware of phishing scams that offer opportunities with Medpace in exchange for sending money. These scammers pose as legitimate employees from actual companies. Please be advised that a Medpace employee will never ask you for a credit card, send you a check, or ask you for any type of payment as part of consideration for a role with our company. All of our careers require that you first complete an online application and go through some sort of interview process.
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