|
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
|
