Quality Assurance Analyst III – Rochester, MN
We are looking for a highly skilled and experienced Quality Assurance Analyst III to join our dynamic team. This role demands a comprehensive understanding of quality system requirements and the capability to independently lead audits, projects, and initiatives. The successful candidate will be crucial in annual audit planning, providing guidance, conflict resolution, and project management. QA Analyst III’s are tasked with overseeing quality and regulatory compliance for manufacturing and other business units. The role involves identifying and mitigating regulatory and compliance risks by continuously monitoring and evaluating facility policies and practices to ensure compliance.
Details:

• Direct Hire with Benefits
  

• Full-time, first shift
  

• Salary depending on experience level, starting at $85,000+/year

Responsibilities:

• Comprehensive Knowledge of Quality System Requirements: Maintain an in-depth understanding of quality system requirements. Keep up to date with industry best practices and evolving quality standards.
  

• Regulatory Compliance: Grasp the links between the quality system and regulatory requirements. Ensure adherence to all applicable regulatory standards.
  

• Independent Auditor: Conduct audits autonomously, showcasing a high level of expertise and attention to detail. Offer recommendations for continuous improvement based on audit findings.
  

• Annual Audit Planning: Lead the annual audit planning process, ensuring thorough coverage of key areas. Collaborate with stakeholders to align audit plans with organizational objectives.
  

• Project Management: Independently lead significant projects and initiatives, acting as project manager. Ensure projects are successfully completed within set timelines.
  

• Conflict Resolution and Compliance Challenges: Help areas navigate conflicts and compliance challenges. Lead root cause analysis and Corrective and Preventive Action (CAPA) investigations.
  

• Project/Assignment Completion: Exhibit a strong commitment to timelines and completion on projects and assignments. Accountability for project deliverables and outcomes.
  

• Support to QA Team Members: Aid QA team members in completing tasks as needed, promoting a collaborative and supportive work environment.
  

• Provides knowledge and guidance to staff on quality concepts and practices.
  

• Ensures risks are escalated and documented appropriately.
  

• Maintain oversight and accountability for third-party service providers, including contract manufacturers and laboratories.
  

• Ensures compliance concerns are prioritized, and necessary resources are allocated.
  

• Works with staff to ensure compliance with regulatory requirements associated with internal and external assessments and in addressing citations.
  

• Develops and updates regulatory and compliance training program tailored to the audience.
  

• Receives, tracks, and responds to customer and regulatory complaints effectively.
  

• Leads the investigation of events in potential regulatory violations, collaborating with relevant parties to resolve issues and take appropriate corrective and preventive actions.

Requirements:

• Bachelor’s degree in a science related field and a minimum of 5 years’ experience in a manufacturing quality assurance role or 3 years’ experience in a biotechnology company.
  

• Knowledge and experience in Good Manufacturing Practices is required. Experience with other requirements ICH, ISO, etc. is preferred.
  

• Exceptional communication skills, attention to detail, the ability to work independently.
  

• Self-motivated with sound judgment. Strong analytic skills with critical thinking.
  

• Ability to write and comprehend complex protocols, programs, and reports.
  

• Strong quality judgment while under pressure, flexible priorities, and tight deadlines.
  

• Prolonged periods of sitting at a desk and working on a computer and must be able to lift up to 15 pounds at times.

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