QA Systems Specialist - eQMS & CSV Projects
MedPharmDurham, North Carolina, United States
Posted September 9, 2025
Full Time
About the Company
MedPharm Ltd is a leading CDMO specializing in the development and manufacturing of topical and transepithelial therapies. With over two decades of experience, they offer comprehensive services including formulation development, clinical trial supply manufacture, and high-potency capabilities. MedPharm stands out by combining cutting-edge research with deep regulatory expertise to deliver tailored solutions that ensure patient success worldwide.
Job Description
This QA Systems Specialist will be responsible for the implementation, migration, validation, and ongoing management of electronic Quality Management Systems (eQMS) and pharmaceutical computerized systems at MedPharm. This role focuses on ensuring compliance with GMPs, Annex 11, and regulatory standards, leading project implementation and support for data management. The specialist will act as a Subject Matter Expert (SME) on MasterControl and provide comprehensive training and monitoring of computer systems.
Requirements
- Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field.
- 3-5 years of experience in computer system validation within a pharmaceutical GMP environment.
- Familiarity with Quality Management Systems and GAMP 5.
- Proven experience with MasterControl.
- Strong understanding of CSV and GxP system implementations.
- Experience in validating and managing Empower CDS.
- Demonstrated experience in project management and change control.
