Quality Assurance Specialist II - Regulatory & Audits

KCAS Bio; Kansas City (MO); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Stock ownership program

KCAS University

Wellness program

Company events

Job summary

KCAS Bio in Kansas City is seeking a Quality Assurance Specialist II to independently perform QA activities ensuring our scientific work meets regulatory requirements. You will review documents, data, and study records and partner with scientific and operations teams.

The role emphasizes audits, CAPAs, deviations, and continuous improvement, plus training junior staff and supporting audit readiness. Join a fast-growing CRO focused on quality integrity and client service in a collaborative,

Qualifications

• Bachelor’s degree in a scientific, quality, or related field.
• 2–3 years of QA/regulatory quality assurance experience.
• Working knowledge of GLP and regulatory requirements.
• Experience reviewing regulated records for accuracy and compliance.
• Experience conducting quality audits and inspections.
• Experience reviewing deviations and CAPAs.
• Strong written and verbal communication skills.
• Ability to manage multiple audits and priorities.

Responsibilities

• Independently perform QA review and approval of documents, data, protocols, reports, and other study-related documentation for accuracy, completeness, and compliance.
• Conduct QA audits and inspections and communicate findings to stakeholders.
• Review deviations, investigations, CAPAs, and other quality events for applicable requirements.
• Review SOPs and controlled documents; support process improvements.
• Maintain QA files, records, databases, and trending information.
• Collaborate with scientific and operational teams to resolve quality issues.
• Support audit readiness and participate in client, internal, and regulatory inspections.
• Provide training to less experienced team members on QA activities.
• Manage multiple audits and assignments independently with timelines.
• Uphold company brand, mission, and values in QA activities.

Skills

QA experience

GLP knowledge

Audit experience

Documentation review

CAPA review

Analytical skills

Written communication

Organizational skills

Collaboration

Computer skills

Quality systems

Data integrity

Continuous improvement

Education

Bachelor’s degree in a scientific, quality, or related field

Job description

KCAS Bio in Kansas City is seeking a Quality Assurance Specialist II to independently perform QA activities ensuring our scientific work meets regulatory requirements. You will review documents, data, and study records and partner with scientific and operations teams.

The role emphasizes audits, CAPAs, deviations, and continuous improvement, plus training junior staff and supporting audit readiness. Join a fast-growing CRO focused on quality integrity and client service in a collaborative,