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:

• Experience in record review and material disposition
• Experience working within SAP (Business Client and ERP, specifically QM module)

Skills & Competencies:

• 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

Physical Requirements:

• 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

RESPONSIBILITIES:

• 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