Vyriad Rochester , MN 55905
Posted 6 days ago
Senior Quality Assurance Analyst
Full time, exempt
Vyriad is seeking a highly skilled and experienced Senior Quality Assurance Analyst to join our dynamic team. As a senior member of the Quality Assurance department, this role requires a full understanding and knowledge of quality system requirements and the ability to independently lead audits, projects, and initiatives. The successful candidate will play a key role in annual audit planning, project management, conflict resolution, and providing guidance to areas navigating compliance challenges.
Senior QA Analyst's are responsible for oversight of quality and regulatory compliance for analytic assay development and testing services, ensuring the quality of our products or services meets the highest standards through continuous monitoring, training, and improvement initiatives. The staff works to identify and reduce regulatory and compliance risks by continuously monitoring and evaluating facility policies and practices to ensure compliance is built into the operational systems. Quality Assurance staff communicate and work effectively with leadership to take necessary actions to mitigate identified risks.
Quality Assurance staff are accountable for the effective implementation of the Quality Management System (QMS) and serves as the subject matter expert on the policies, processes, and procedures of the QMS by developing a broad knowledge of the practice, business, and technology as it relates to product manufacturing.
In addition to traditional QA responsibilities, this role involves delivering quality training, identifying areas for improvement, designing and implementing quality system enhancements, and fostering innovation within the quality process.
Supervisory Responsibilities
None
Duties and Responsibilities
Full Understanding of Quality System Requirements:
Possess a comprehensive understanding and knowledge of quality system requirements
Stay abreast of industry best practices and evolving quality standards
Regulatory Compliance:
Understand the connections between the quality system and regulatory requirements
Ensure compliance with all applicable regulatory standards
Independent Auditor:
Independently conduct audits, demonstrating a high level of expertise and attention to detail
Provide recommendations for continuous improvement based on audit findings
Annual Audit Planning:
Lead the annual audit planning process, ensuring comprehensive coverage of key areas
Collaborate with relevant stakeholders to align audit plans with organizational goals
Project Management:
Lead large projects and initiatives independently, functioning as a project manager
Ensure successful completion of projects within established timelines
Conflict Resolution and Compliance Challenges:
Assist areas in navigating conflict and compliance challenges
Direct root cause and Corrective and Preventive Action (CAPA) investigations as needed
Project/Assignment Follow-Through:
Demonstrate a commitment to timely and complete follow-through on projects and assignments
Maintain accountability for project outcomes and deliverables
Assistance to QA Team Members:
Assist other QA team members with task completion as needed
Foster a collaborative and supportive team environment
Other Responsibilities
Provides knowledge and expertise to Vyriad staff on quality concepts and practices
Ensures risks are escalated and documented appropriately
Maintains control and takes responsibility for third-party service providers (contract manufacturers, contract laboratories, etc.)
Ensures compliance concerns are prioritized and resources identified
Works with staff to ensure compliance with regulatory requirements associated with internal and external assessments and responses to citations
Develops regulatory and compliance training program for the intended audience. Maintains program and keeps it up to date.
Receives, tracks, and responds to customer and regulatory complaints
Leads the investigation of events that appear to be associated with regulatory violations. Works with relevant parties to resolve issue and take appropriate corrective and preventive action.
Conduct routine quality training sessions for staff to ensure understanding and adherence to quality standards
Identify areas for improvement within the quality system through the development and analysis of monitoring, measuring, and metrics
Design and initiate quality system improvements to address identified areas of improvement and enhance overall quality performance
Innovate new and effective ways to meet quality objectives, promote engagement, and drive continuous improvement within the organization
Communicate improvement and innovation ideas to leadership, providing recommendations and insights for strategic decision-making
Maintain effective communication channels with cross-functional teams to ensure alignment on quality goals and initiatives
Collaborate with other departments to integrate quality processes and standards into their workflows as necessary
Stay current with industry best practices and technological advancements to enhance the effectiveness of the quality assurance function
Provide support during audits and regulatory inspections as needed
Education and Experience Requirements
Required Skills and/or Qualifications
Knowledge and experience in FDA current Good Manufacturing Practices for product manufacturing is required
Additional experience with other requirements (ICH, ISO, etc.) is highly desirable
Attention to detail-oriented and the ability to work independently and productively with minimal direction
Self-motivated and ability to exercise sound judgment
Strong analytic skills coupled with critical thinking skills are essential in this role
Must have demonstrated capacity to comprehend complex protocols, programs, and situations
The ability to exercise good judgment while under pressure and tight deadlines, and strong coping skills are required
Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities
Extensive experience in quality assurance, with a proven track record in a senior role
In-depth understanding of quality system requirements and regulatory standards
Strong project management skills and experience leading large initiatives
Independent auditor certification and experience preferred
Strong understanding of quality management principles, methodologies, and tools
Proven experience in delivering quality training sessions to diverse audiences
Proficiency in data analysis and interpretation to drive quality improvements
Excellent problem-solving skills with the ability to identify root causes and implement effective solutions
Strong communication and interpersonal skills, with the ability to effectively engage with stakeholders at all levels
Demonstrated ability to work independently with minimal supervision while maintaining alignment with organizational goals
Experience with quality management systems (QMS) and regulatory requirements is preferred
Certifications such as Six Sigma, Lean, or Certified Quality Auditor (CQA) are a plus
Physical Requirements
Prolonged periods of sitting at a desk and working on a computer
Must be able to lift up to 15 pounds at times
Vyriad