What are the responsibilities and job description for the MasterControl Programmer position at Accentuate Staffing?
Accentuate Staffing is partnering with a fast-growing, pharmaceutical CDMO who is hiring for a MasterControl Programmer to join their team! This is a direct hire or contract to hire opportunity, offering competitive pay while working onsite. The ideal candidate has the ability to lead and support the implementation, migration, validation, and ongoing management of key eQMS and pharmaceutical computerized systems.
Responsibilities
- Acts as SME on MasterControl, and other digital tools used to manage pharmaceutical quality data, ensuring compliance with GMPs and applicable regulatory standards.
- Provide training, troubleshooting, and ongoing support for eQMS platforms and MasterControl.
- Owns and manages system lifecycle documentation including; URS, Risk Assessments, IQ/OQ/PQ, Data Migration and SOPs.
- Maintains compliance and audit readiness for all electronic systems.
- Provides regular updates to Senior Management and key stakeholders highlighting risks and issues with existing systems, new system implementation and development
- Mentors users and super-users; deliver training programs on validated systems.
Requirements
- Proven MasterControl SME, executing configuration, administration and user training.
- Demonstrable success in leading system migrations or large-scale QMS digitalization projects.
- Strong working knowledge of CSV and GxP System implementation in a regulated pharmaceutical environment.
- Experience in writing and maintaining validation documentation in line with GAMP 5.
- Hands-on CSV activities related to Empower CDS:
- Validation of new Empower installations and version upgrades.
- Data migration and system archiving.
- Managing audit trails, user access, and data integrity in Empower.
- Bachelor’s degree is desirable but not required.
