The position is responsible for providing support for R&D Quality activities related to the Merz Aesthetics R&D electronic Quality Management Systems (eQMS). This position is responsible for maintaining all procedural documents and records that make up Merz Quality System and for providing support to all functional areas within Merz including training management. Activities include, but not limited to Procedural Document Management and Training oversight for various R&D functions and the Quality Operations department to assure QMS alignment and compliance. Assists in training others on related document control and training activities. This position works with minimal supervision, requires a high degree of interaction with other Merz employees and resolves more complex issues requiring evaluation of identifiable factors. Standard operating procedures provide guidance in performing the activities required.
location: Raleigh, North Carolina
job type: Contract
salary: $25.00 - 27.88 per hour
work hours: 9 to 5
R&D Procedural Document Management
- Assist with the management of procedural documents and training activities as defined by the Merz electronic Quality Management system, department, project team, and corporate objectives.
- Co-Lead SOP Committee and all associated activities
- Assist with training documentation program and job code creation
- Assist with the management of procedural document and training inquiries tracker
Quality Management System Training Support
- Support overall Quality Systems training by creating/revising trainee accounts monitoring training and sending out notices when necessary to ensure on time training completion.
General R&D Support
- Global support for all Quality Management System, Procedural Document Management and Training activities for R&D
- Support R&D related SOP creation and maintenance
- Assist in ensuring applicability of current quality policies, procedures, and objectives by keeping informed of the latest updates/modifications related to applicable regulations (ISO, Ministries of Health (FDA, EMA, Health Canada, TGA, ANVISA, etc.)).
- Provide support to other regulatory staff as needed and perform duties and assignments as required. Communicate and raise questions/issues to the attention of regulatory management. Additional duties as needed to support the business and overall company objectives.
skills: GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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