Specialist III, Quality Systems
Enable Injections IncCincinnati, OH, United States22 hours ago
Job type
- Full-time
Job descriptionExperience in record review and material disposition Experience working within SAP (Business Client and ERP, specifically QM module) Strong computer skills including Microsoft Office and databases / excel spreadsheets Strong communication skills - verbal and written Solid understanding of Quality System requirements (i.e., CAPA, nonconformances, etc.) in a regulated medical device or pharmaceutical environment Strong understanding of device and / or pharmaceutical regulatory and compliance requirements Exemplifies flexibility and resourcefulness; responds deftly to a variety of challenges and situations Ability to understand complexity, anticipate problems, and proactively diagnose Plan and carry out sequential projects Ability to analyze problems and troubleshoot solutions Begin to demonstrate the ability to foster teamwork, collaboration, negotiation, and influencing others Excellent time management skills Must be able to remain in a stationary position for extended periods of time Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc. Position requires being physically present on the premises during regular company hours or as approved by management Conducts and oversees Training Program of the Quality System Oversee daily tasks of uploading and managing training content, courses and curricula within the Learning Management System (SuccessFactors), ensuring training requests (i.e., add / remove item, curriculum, quiz, etc.) are appropriately applied and functioning Monitor system performance, troubleshoot issues within scope of Quality related matters and coordinate technical support as needed Collaborate with subject matter experts to develop and update training content that reflect industry best practice Support the development and implementation of protocols for maintaining accuracy and integrity of training records Generate and analyze reports on training completion rates, learner performance, and compliance metrics to support organizational goals Facilitate training sessions for users and stakeholders to educate personnel on how to navigate the LMS Conduct Train-the-Trainer, Annual Curricula Review and New Hire orientation Deploy quality system training, including GMP, GDP, and FDA Readiness training programs Report routine Quality metrics to the Senior Management team Support the maintenance of Document Control release, Document Control Storage Room, and electronic Quality System records Directly supports the Director, Quality Assurance and Senior Manager, Quality Systems with Notified Body ISO13485 Audits, Customer Audits, and Regulatory Body Inspections (including FDA) Execute other duties and projects, as assigned by the Director, Quality Assurance and / or Senior Manager, Quality Systems
Location : Onsite
Status Type : Full Time
QUALIFICATIONS
Required :
- Bachelor's Degree or equivalent combination of education, training, and experience
- 4 years of experience in Quality Assurance for the pharmaceutical or medical device industries
Preferred :
Skills & Competencies :
Physical Requirements :
RESPONSIBILITIES :
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Quality System Specialist • Cincinnati, OH, United States
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