Quality Assurance Specialist II

KCAS Bio • Kansas City, MO

1d

About The Position

The Quality Assurance Specialist II independently performs quality assurance activities to help ensure KCAS Bio’s scientific work complies with applicable regulatory requirements, guidance documents, company policies, and procedures. The role applies knowledge of quality systems and regulatory requirements to review documents and data, conduct audits and inspections, support investigations, and work with scientific and operational teams to maintain quality and data integrity.

The specialist works with increasing independence and serves as a quality resource across the organization. The position also supports audit and inspection readiness, continuous improvement of quality systems, and guidance and training for less experienced team members.

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, 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, including the ability to identify quality or compliance concerns.
• Strong written and verbal communication skills, including the ability to communicate findings clearly and professionally.
• Strong organizational skills and the ability to independently manage multiple assignments, audits, and priorities.
• Ability to interpret and apply SOPs, regulatory requirements, and established quality procedures.
• Ability to collaborate effectively with scientific, operational, and other cross-functional teams.
• Strong computer skills and the ability to work effectively with quality systems, databases, and other applicable software.
• Demonstrated commitment to quality, data integrity, accountability, and continuous improvement.

Nice To Haves

• 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.

Responsibilities

• Independently review and approve documents, data, protocols, reports, and other study-related documentation for accuracy, completeness, and compliance.
• Conduct quality assurance audits and inspections, and prepare and communicate findings to Study Directors, Principal Investigators, management, and other appropriate stakeholders.
• Review deviations, investigations, corrective and preventive actions, and other quality events, and provide guidance on applicable quality and regulatory requirements.
• Review SOPs and other controlled documents and support the development and continuous improvement of QA processes and quality systems.
• Maintain accurate QA files, records, databases, and trending information, and identify potential quality or compliance trends requiring additional review.
• Partner with scientific and operational teams to resolve quality and compliance issues in a professional, collaborative, and client-focused manner.
• Support audit and inspection readiness and participate in client, internal, and regulatory inspections as appropriate.
• Provide guidance and training to less experienced team members on routine QA activities, quality systems, and applicable procedures.
• Independently manage multiple audits, reviews, and assignments while maintaining accuracy and meeting established timelines.
• Perform duties in a manner that supports the company brand, mission, vision, and values.

Benefits

• Company-sponsored events, including food trucks, family days, and spirit days.
• Career development through KCAS University.
• Employee connections and opportunities related to wellness, inclusion, and community outreach.
• Stock ownership program.
• Access to the latest technology.
• Paid time off to volunteer.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level