Quality Assurance Specialist

Quality Assurance On The Floor (2nd Shift)

• Review and approve product batch records and associated technical documentation to ensure completeness, accuracy, and compliance with internal procedures and regulatory requirements.
• Evaluate and approve documentation related to validation activities, deviations, change control activities, and media fills, ensuring that all quality and regulatory standards are met.
• Track, report, and define continuous improvement goals related to quality assurance and production processes.
• Investigate deviations and nonconformances, determine root causes, and support the development and implementation of effective corrective and preventive actions (CAPA).
• Communicate investigation findings, CAPA outcomes, and process improvements clearly and promptly to the Process Team and other relevant stakeholders.
• Audit production processes and laboratory activities for compliance with global and local procedures, regulatory guidelines, and internal quality standards.
• Create new or revise existing procedures and controlled documents as process or regulatory changes occur, ensuring documentation remains current and compliant.
• Develop training plans and deliver training to colleagues, including those outside the immediate area of responsibility, to ensure understanding and adherence to quality procedures.
• Contribute ideas to improve site performance and operational efficiency and work collaboratively with colleagues at all levels to implement improvements.
• Exercise sound judgment to assess the acceptability of product based on documentation provided, making decisions with minimal supervision when appropriate.
• Maintain a high level of professionalism in all interactions with internal and external customers, representing the quality function effectively.

• Associate's Degree in a science-related field with relevant industry experience, or a Bachelor's Degree in a science-related field such as Biology or Chemistry.
• Previous experience working in a biological production environment, ideally involving vaccines or similar products.
• Ability to make decisions with minimal supervision regarding the acceptability of product based on documentation provided.
• Consistent demonstration of professionalism in interactions with internal and external customers.
• Proven ability to formulate new ideas for improving site performance and operational efficiency.
• Ability to work cohesively and collaboratively with colleagues at all levels of the organization.
• Curious mindset with a strong desire to understand processes and identify opportunities for improvement.
• Courage to raise concerns, challenge the status quo constructively, and support quality-focused decisions.
• Driven and self-motivated approach to work, with a focus on achieving high standards of quality and compliance.

The position follows a Monday through Friday schedule, typically from 2:00 p.m. to 10:00 p.m., requiring comfort with an afternoon to evening shift.

This is a Permanent position based out of Fort Dodge, IA.

The pay range for this position is $65000.00 - $95000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

• Paid vacations and holidays.
• 401K retirement plan.
• Health insurance coverage.

This is a Permanent position based out of Fort Dodge, IA.

This position is anticipated to close on Nov 18, 2026.

This is a fully onsite position in Fort Dodge,IA.

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