Quality Assurance Specialist II
KCAS Bio
Summary
Independently perform quality assurance activities that help ensure scientific work complies with applicable regulatory requirements, guidance documents, company policies, and procedures.
Job description
Responsibilities
- Independently perform Quality Assurance review and approval of documents, data, protocols, reports, and other study-related documentation for accuracy, completeness, and compliance
- Conduct QA audits and inspections and prepare and communicate findings to Study Directors, Principal Investigators, management, and other stakeholders
- Review deviations, investigations, corrective and preventive actions, and other quality events and provide guidance regarding applicable quality and regulatory requirements
- Review SOPs and other controlled documents and support the development and continuous improvement of Quality Assurance processes and quality systems
- Maintain accurate QA files, records, databases, and trending information and identify potential quality or compliance trends
- Partner with scientific and operational teams to resolve quality and compliance issues
- Support audit and inspection readiness and participate in client, internal, and regulatory inspections
- Provide guidance and training to less experienced team members on routine QA activities, quality systems, and applicable procedures
- Manage multiple audits, reviews, and assignments independently while maintaining accuracy and meeting established timelines
Qualifications
- Bachelor's degree in a scientific, quality, or related field
- At least 2–3 years of relevant Quality Assurance, regulated laboratory, pharmaceutical, biotechnology, CRO, or related experience
- Working knowledge of GLP and applicable regulatory requirements, guidance documents, and quality systems
- Experience reviewing scientific documentation, data, protocols, reports, or other regulated records for accuracy and compliance
- Experience conducting or supporting quality audits and inspections
- Experience reviewing deviations, investigations, CAPAs, or other quality events
- Strong analytical skills and attention to detail
- Strong written and verbal communication skills
- Strong organizational skills with the ability to independently manage multiple assignments, audits, and priorities
- Ability to interpret and apply SOPs, regulatory requirements, and established quality procedures
- Ability to effectively collaborate with scientific, operational, and other cross-functional teams
- Strong computer skills with the ability to work effectively with quality systems, databases, and other applicable software
- A demonstrated commitment to quality, data integrity, accountability, and continuous improvement
Preferred Qualifications
- Quality Assurance experience within a CRO, pharmaceutical, biotechnology, or bioanalytical laboratory environment
- Experience supporting GLP-regulated bioanalytical studies
- Experience participating in client or regulatory audits and inspections
- Experience providing training or guidance to less experienced Quality Assurance staff
Requirements
- Bachelor's degree in a scientific, quality, or related field
- At least 2–3 years of relevant Quality Assurance, regulated laboratory, pharmaceutical, biotechnology, CRO, or related experience
- Working knowledge of GLP and applicable regulatory requirements, guidance documents, and quality systems
- Experience reviewing scientific documentation, data, protocols, reports, or other regulated records for accuracy and compliance
- Experience conducting or supporting quality audits and inspections
- Experience reviewing deviations, investigations, CAPAs, or other quality events
- Strong analytical skills and attention to detail
- Strong written and verbal communication skills
- Strong organizational skills with the ability to independently manage multiple assignments, audits, and priorities
- Ability to interpret and apply SOPs, regulatory requirements, and established quality procedures
- Ability to effectively collaborate with scientific, operational, and other cross-functional teams
- Strong computer skills with the ability to work effectively with quality systems, databases, and other applicable software
- A demonstrated commitment to quality, data integrity, accountability, and continuous improvement
Benefits
- Stock Ownership Program
- Professional Development
- Wellness Programs
- Community Outreach
- Paid Volunteer Time Off
- Company Sponsored Events
Company overview
KCAS Bio is a leading global bioanalytical contract research organization (CRO) with over 45 years of experience in supporting drug development. Founded in 1979 and headquartered in Olathe, Kansas, the company provides comprehensive bioanalytical services from early discovery through clinical development and commercialization. With a team of approximately 375 employees and facilities across the United States, Europe, and Australia, KCAS Bio has supported the development of over 315 approved drugs and developed more than 6,200 proprietary and non-proprietary assays. The company specializes in biomarker testing, small and large molecule bioanalysis, immunogenicity testing, flow cytometry, molecular services, and clinical kitting. KCAS Bio maintains an exceptional regulatory compliance record, having successfully completed more than 20 FDA audits with no major findings. Their global presence and strategic alliances enable them to serve pharmaceutical and biotechnology clients worldwide with high-quality, GLP/GCP-compliant services that accelerate the development of life-changing therapies.