Quality Assurance Specialist II

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Provide support to the Quality Compliance Group by maintaining the day to day data entry for metric systems of key performance indicators within Technical Operations. Interact with Quality business process owners to request metric data and respond to inquiries regarding metric generation. Assist in keeping databases current by maintaining lists critical to the metric program. Provide assistance in Quality Compliance where necessary.

• Experience with Quality Systems required
• Ability to speak effectively and communicate directly with all levels of personnel in a global environment
• Ability to write routine correspondence for internal and external customer communications
• Excellent attention to detail
• Strong organizational skills
• Computer literate—experience with Microsoft Office (specifically Excel, Access and PowerPoint) and Track Wise preferred
• Strong self-motivation and ability to work under limited supervision
• Ability to work in, and be adaptable to, a diverse, dynamic, and team-oriented environment
• Strong compliance mindset
• Ability to work independently
• Ability to solve problems and analyze data
• Work under challenging deadlines and be accountable for completing work within specified time periods

Qualifications:

• Bachelor's degree is required/ Associate's degree is accepted as long as they have relevant Quality Assurance experience
• Experience in commercial quality assurance (marketed jobs, not just on the clinical and research side) is required
• Quality Systems experience is required- CAPA, deviation, change control systems
• Track Wise is not required (nice to have)
• 2+ years of experience working within a Pharmaceutical/ Quality Assurance field, no limits when it comes to years of experience
• Open to experience in Medical Devices as well

All your information will be kept confidential according to EEO guidelines.