Quality Assurance Specialist II

KCAS Bio, Kansas City

The role

Performing critical work that impacts our industry and our world’s health while problem solving and innovating in the field – that is what a Quality Assurance Specialist II at KCAS Bio gets to do every day. If that gets you excited too, then maybe working as an Quality Assurance Specialist II at KCAS Bio is the role for you.

When you work as a QA Specialist II at KCAS, you get to further our mission by independently performing quality assurance activities that help ensure our scientific work complies with applicable regulatory requirements, guidance documents, company policies, and procedures. You will apply your knowledge of quality systems and regulatory requirements to perform document and data reviews, conduct audits and inspections, support investigations, and partner with scientific and operational teams to maintain the quality and integrity of our work.

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Quality Assurance Specialist II

KCAS Bio, Kansas City

Posted pay

Pay not posted

Location: Kansas City
Work type: Hybrid
Level: Not given
Posted: 4 days ago
Last check: 6 h ago
Job type: Software engineering

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About KCAS Bio: funding, hiring and pay

KCAS Bio

About KCAS Bio: funding, hiring and pay

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The role

What you will do

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 appropriate 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 requiring additional review
Partner with scientific and operational teams to resolve quality and compliance issues while maintaining a professional, collaborative, and client-focused approach
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
Manage multiple audits, reviews, and assignments independently while maintaining accuracy and meeting established timelines
Perform all aspects of the job in a way that supports company brand and supports company mission, vision, and values

To qualify specifically for this role, you will have

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 with the ability to identify quality or compliance concerns
Strong written and verbal communication skills with the ability to communicate findings clearly and professionally
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

Quality Assurance Specialist II

The role

Quality Assurance Specialist II

The role

What you will do

To qualify specifically for this role, you will have

What you need

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Pay and benefits

About KCAS Bio

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