QA Specialist II: Audits, Compliance & Data Review

Integris BioServices, LLC dba KCAS Bioanalytical and Biomarker Services; Kansas City (MO); Sur place; USD 70 000 - 95 000; Plein temps

Avantages offerts par ce poste

Stock ownership program

Paid time off to volunteer

KCAS University

Résumé du poste

KCAS Bioanalytical and Biomarker Services is seeking a Quality Assurance Specialist II to support QA activities ensuring GLP compliance and regulatory alignment. You will perform document and data reviews, participate in audits, and collaborate with scientific and operational teams to uphold quality standards.

The role emphasizes independent work, strong attention to detail, and the ability to manage multiple QA tasks with deadlines, contributing to overall data integrity and client satisfaction.

Qualifications

• Bachelor's degree in a scientific, quality, or related field.
• 2–3 years of relevant QA, regulated lab, pharma, CRO, or related experience.
• Working knowledge of GLP and regulatory requirements and quality systems.
• Experience reviewing scientific docs, data, protocols, or other records for accuracy and compliance.
• Experience conducting or supporting QA audits and inspections.
• Experience reviewing deviations, investigations, CAPAs, or other quality events.

Responsabilités

• Audit and inspect study documents, data, protocols, and reports for accuracy and compliance.
• Communicate QA findings to study directors, investigators, and management.
• Review deviations and CAPAs and guide applicable quality requirements.
• Maintain QA files, databases, and trending information with accuracy.
• Support audit readiness and participate in client, internal, and regulatory inspections.
• Provide training and guidance on routine QA activities and procedures.

Connaissances

QA audits

Documentation review

Regulatory compliance

Data integrity

Cross-functional collaboration

Formation

Bachelor's degree in science/quality

Description du poste

KCAS Bioanalytical and Biomarker Services is seeking a Quality Assurance Specialist II to support QA activities ensuring GLP compliance and regulatory alignment. You will perform document and data reviews, participate in audits, and collaborate with scientific and operational teams to uphold quality standards.

The role emphasizes independent work, strong attention to detail, and the ability to manage multiple QA tasks with deadlines, contributing to overall data integrity and client satisfaction.