eQMS Specialist
Accentuate Staffing is partnering with a fast-growing, CDMO who is in search of an eQMS Specialist to join their team. This is a direct hire or contract to hire opportunity, offering competitive pay and benefits while working onsite. This person will be critical in be leading and supporting the implementation, migration, validation, and ongoing management of key eQMS and pharmaceutical computerized systems.
Responsibilities:
- Serve as the primary point of contact for all MasterControl-related questions and issues across three sites.
- Own and maintain QMS workflows within the MasterControl platform.
- Provide day-to-day support and training to users to ensure proper utilization of the system.
- Collaborate with Quality and Compliance teams to ensure workflows meet regulatory standards.
- Assist in QMS documentation, updates, and process improvements.
- Participate in audits or inspections related to electronic quality systems.
Requirements:
- Bachelors degree combined with 2+ years working in GMP-regulated, pharmaceutical environments is highly preferred.
- Demonstrated experience performing user training, configuration and administration with MasterControl or similar eQMS platforms.
- Hands-on experience executing computer system validation activities including validation installations and version upgrades.
- Proven experience leading system migrations or large-scale QMS digitalization projects.
- Strong understanding of quality system processes and workflows.
- Ability to work independently and manage responsibilities across multiple sites.
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