MedPharm · 1 month ago
QA Systems Specialist - eQMS & CSV Projects
Durham, NC
Full-time
Onsite
Mid Level
3+ years expMedPharm is focused on implementing and managing electronic Quality Management Systems (eQMS) and pharmaceutical computerized systems. The QA Systems Specialist will lead these initiatives, ensuring compliance with industry regulations and providing training and support for digital tools used in quality management.
BiotechnologyDeveloper PlatformManufacturingPharmaceutical
Responsibilities
To effectively manage key Pharmaceutical Computerized System projects: delivering according to plan
To have a good working knowledge of electronic Quality Management System and its practical implementation at MedPharm
Lead and support the implementation of new tools in the electronic Quality Management System (e.g., MasterControl), ensuring smooth transition and compliance throughout all phases
Act as the Subject Matter Expert (SME) for eQMS platforms including MasterControl – provide training, troubleshooting, and ongoing support
Own and manage system lifecycle documentation – URS, risk assessments, IQ/OQ/PQ, data migration plans, and SOPs
To promote a culture of acceptance to change in support of an ongoing programs of companywide improvement
Provide regular updates to Senior Management and key stakeholders including metrics reports highlighting risks and issues with existing systems, and new system implementation and development
Support employees working on Computerized System projects such as computerized lab equipment
Ensure adherence to GMPs, Annex 11 & 15, GLP and latest industry guidance during project activities
To ensure that all key process personnel are appropriately trained prior to implementation of a new Computerized System procedure
Drive post-implementation reviews and continuous improvement of computerized systems
To support the eQMS as a subject matter expert on Computer systems used to store and process pharmaceutical data
Maintain compliance and audit readiness for all electronic systems
To act as the Records Archivist and manage archiving process
Mentor users and super-users; deliver training programs on validated systems
Perform other duties as requested by management
Qualification
Required
Bachelor's in Life Sciences, Engineering, Computer Science, or related discipline desirable but not essential
Training in Computer System Validation in a Pharmaceutical GMP environment and familiarity with GAMP 5 with 3-5 years experience working in the pharmaceutical industry preferred
Proven experience working with MasterControl, or similar eQMS platforms – configuration, administration, and user training
Strong working knowledge with CSV and GxP system implementations in a regulated pharmaceutical or life sciences environment
Hands-on experience with CSV activities relating to Empower CDS, including validation of new Empower installations and version upgrades, data migration and system archiving, management of audit trails, user access, and data integrity in Empower
Demonstrable success in leading system migrations or large-scale QMS digitalization projects
Experience in writing and maintaining validation documentation in line with GAMP 5
Good working knowledge of Computer System Validation
Familiar with electronic quality management systems (eQMS)
Familiar with environmental monitoring systems
Experience working within a Quality function on computer systems integration projects
Highly organized
Effective communicator able to translate technical concepts to non-technical users
Strong project management and change control skills
Able to influence and drive adoption of new systems across multidisciplinary teams
Preferred
Familiar with Quality Management Systems is desirable (Deviations, Change Controls, CAPAs, etc.)
Company
MedPharm
MedPharm is a world-leading contract provider of topical and transdermal product design and development services.
51-200 employees
H1B Sponsorship
MedPharm has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2023 (3)
2022 (2)
2021 (2)
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Ampersand Capital Partners
2024-07-08Acquired
2018-03-26Series Unknown
Recent News
2026-01-09
2024-11-25
Company data provided by crunchbase