Quality Assurance Analyst III Job Listing at Kelly Services in Rochester, MN (Job ID 9595339)

Description

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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

 Apply on company website