Senior Quality Assurance Specialist - RELOCATION to Minnesota Required

I am currently partnering with an innovative biotechnology company focused on developing oncolytic virotherapy treatments for cancer. They are seeking a skilled Quality Assurance Analyst III/ Senior Quality Assurance Analyst to join their dynamic team in Minnesota. The successful candidate will play a key role in audit planning, project management, conflict resolution, and providing guidance to teams navigating compliance challenges.

As a QA Analyst III, you will be responsible for overseeing quality and regulatory compliance for analytic assay development and testing services. You will work to identify and reduce regulatory and compliance risks by continuously monitoring and evaluating facility policies and practices to ensure compliance is integrated into the operational systems. You will communicate effectively with leadership to take necessary actions to mitigate identified risks and ensure smooth project implementation.

Key Responsibilities:

• Possess a comprehensive understanding and knowledge of quality system requirements.
• Stay abreast of industry best practices and evolving quality standards.
• Understand the connections between the quality system and regulatory requirements.
• Ensure compliance with all applicable regulatory standards.
• Independently conduct audits, demonstrating a high level of expertise and attention to detail.
• Provide recommendations for continuous improvement based on audit findings.
• Lead the annual audit planning process, ensuring comprehensive coverage of key areas.
• Collaborate with relevant stakeholders to align audit plans with organizational goals.
• Lead large projects and initiatives independently, functioning as a project manager.
• Ensure successful completion of projects within established timelines.
• Assist areas in navigating conflict and compliance challenges.
• Direct root cause and Corrective and Preventive Action (CAPA) investigations as needed.
• Demonstrate a commitment to timely and complete follow-through on projects and assignments.
• Maintain accountability for project outcomes and deliverables.
• Assist other QA team members with task completion as needed.
• Foster a collaborative and supportive team environment.
• Develops and oversees the analytical systems compliance program.
• Provides knowledge and expertise to testing personnel on quality concepts and practices.
• Ensures analytical service risks are escalated to management.
• Maintains control and takes responsibility for third-party service providers (contract manufacturers, contract laboratories, etc.).
• Ensures compliance concerns are prioritized and resources identified.
• Performs review of analytical testing documents for clarity and compliance.
• Works with scientific 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.
• Lead the investigation of events that appear to be associated with regulatory violations. Work with relevant parties to resolve issue and take appropriate corrective and preventive action.

Education & Experience Requirements:

• Bachelor’s degree in a science-related field.
• A minimum of 5 years of experience in a manufacturing quality control/quality assurance role.

Required Skills and Qualifications:

• Strong knowledge of FDA current Good Manufacturing Practices (cGMP) and other regulatory standards (e.g., Good Laboratory Practices, ISO).
• Exceptional communication skills (written, verbal, and listening), with the ability to work independently and handle complex situations.
• Strong analytic and critical thinking skills with the capacity to understand and apply complex protocols and procedures.
• Demonstrated experience with project management, particularly in leading large, cross-functional initiatives.
• Independent auditor certification and extensive auditing experience.

Note:

This role requires relocation to Minnesota. Candidates must be willing to relocate for this opportunity.

If you are passionate about quality assurance and regulatory compliance and are ready to take on a challenging and impactful role in the biotechnology field, we encourage you to apply!