Quality Assurance Process Team Device Assembly and Packaging

Responsibilities

• Active presence in operational areas
• Quality oversight for the verification and qualification of the manufacturing equipment, buildings, including review of test cases, test execution, discrepancy resolution, etc.
• Provides guidance for leveling, resolving, reviewing and approving deviations and change controls
• Demonstrate a comprehensive understanding of the process and its associated equipment, facilities, computer systems and operations
• Lead and establish annual quality floor time plan
• Support resolution of batch documentation such as alarm response, exceptions, etc
• Support asset qualification monitoring reviews and reports
• Respond to operational issues outside of core business hours / days
• Attend and provide update on quality at daily process team meeting
• Support the site organization in building technical capability, in Quality, the project team, and area process teams, including mentoring and training of new Quality staff
• Resolve or escalate any compliance issues to Quality Management
• Identify and implement continuous improvements
• Measure, maintain, and achieve quality metrics
• Serve as positive role models for their Process Team peers and for the organization in general

Requirements

• Bachelor's or equivalent degree in a scientific field
• 4+ years' experience in Quality pharmaceutical manufacturing required
• Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation
• Use process knowledge and control strategy to make quality decisions
• Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing
• Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills
• Ability to work independently as a Quality SME with minimal supervision
• Proficiency with computer systems including SAP, Trackwise, MES etc.
• Maintain a safe work environment
• Work 8 hour shifts onsite (not eligible for remote work)
• Work overtime as required

Basic Requirements

• Legal authorization to work in the United States