QA Specialist I

Kcasbio; Kansas City (MO); On-site; USD 52,000 - 70,000; Full time

Job summary

KCAS Bio, a fast-growing CRO in Kansas City, invites a QA Specialist I to support quality assurance activities ensuring regulatory compliance across documents, data, SOPs and records. You will participate in audits, data reviews, and trend analyses while collaborating with scientists and operations to maintain quality and accuracy.

You will grow within our Quality organization as you learn our systems and regulatory environment, contributing to training and continuous improvement initiatives and

Qualifications

• Bachelor’s degree in a related field
• At least 1 year of work experience in a professional environment
• Strong analytical skills and attention to detail, including basic math skills
• Good written and verbal communication skills with the ability to communicate effectively with internal and external clients
• Good organizational skills with the ability to manage multiple assignments and priorities
• Good computer skills and the ability to learn quality systems, databases, and other applicable software
• Ability to read, understand, and follow established procedures and requirements
• Ability to effectively collaborate with multiple levels and functions throughout the organization
• Ability to seek clarification, receive guidance, and apply feedback while developing greater independence in the role
• A commitment to quality, accuracy, accountability, and continuous improvement

Responsibilities

• Perform Quality Assurance review and approval of documents, data, protocols, and reports
• Perform QA audits and inspections and prepare and distribute audit reports to Study Directors, Principal Investigators, and/or management in a timely manner
• Review deviations and investigations with guidance from more experienced Quality Assurance team members
• Maintain accurate Quality Assurance files, records, and databases and support data analysis and trending as needed
• Assist with the Quality Assurance review of Standard Operating Procedures (SOPs)
• Support Quality Assurance and quality system continuous improvement initiatives
• Demonstrate strong attention to detail when reviewing scientific documentation and data for accuracy, completeness, and compliance
• Gather clarification and ask appropriate questions to ensure a thorough understanding of assigned tasks and priorities
• Collaborate effectively with scientific, operational, and other cross-functional teams throughout the organization
• Demonstrate a client-focused approach through professional communication, responsiveness, and follow-through
• Assist with training activities related to routine Quality Assurance data review as needed
• Manage multiple assignments and priorities 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

Skills

Attention to detail

Analytical skills

Written and verbal communication

Organizational skills

Computer literacy

Collaboration

Questioning and seeking guidance

Commitment to quality

Education

Bachelor’s degree in a related field

Job description

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

When you work as a QA Specialist I at KCAS, you get to further our mission by supporting quality assurance activities that help ensure our scientific work complies with applicable regulatory requirements, guidance documents, company policies, and procedures. You will build your knowledge of quality systems while performing document and data reviews, supporting audits and inspections, and working collaboratively with scientific and operational teams across the organization.

Our Quality Assurance team partners closely with scientific and operational teams to maintain the quality, integrity, and compliance of the bioanalytical work performed at KCAS. As a Quality Assurance Specialist I, you will develop your understanding of our quality systems and regulatory environment while building the skills needed to grow within the Quality organization.

• Perform Quality Assurance review and approval of documents, data, protocols, and reports
• Perform QA audits and inspections and prepare and distribute audit reports to Study Directors, Principal Investigators, and/or management in a timely manner
• Review deviations and investigations with guidance from more experienced Quality Assurance team members
• Maintain accurate Quality Assurance files, records, and databases and support data analysis and trending as needed
• Assist with the Quality Assurance review of Standard Operating Procedures (SOPs)
• Support Quality Assurance and quality system continuous improvement initiatives
• Demonstrate strong attention to detail when reviewing scientific documentation and data for accuracy, completeness, and compliance
• Gather clarification and ask appropriate questions to ensure a thorough understanding of assigned tasks and priorities
• Collaborate effectively with scientific, operational, and other cross-functional teams throughout the organization
• Demonstrate a client-focused approach through professional communication, responsiveness, and follow-through
• Assist with training activities related to routine Quality Assurance data review as needed
• Manage multiple assignments and priorities 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

• Bachelor’s degree in a related field
• At least 1 year of work experience in a professional environment
• Strong analytical skills and attention to detail, including basic math skills
• Good written and verbal communication skills with the ability to communicate effectively with internal and external clients
• Good organizational skills with the ability to manage multiple assignments and priorities
• Good computer skills and the ability to learn quality systems, databases, and other applicable software
• Ability to read, understand, and follow established procedures and requirements
• Ability to effectively collaborate with multiple levels and functions throughout the organization
• Ability to seek clarification, receive guidance, and apply feedback while developing greater independence in the role
• A commitment to quality, accuracy, accountability, and continuous improvement

(Please note this is a representative summary of responsibilities, not a comprehensive or exclusive list of the duties to be performed in any position. Employees must follow instructions and perform additional duties as requested.)

WHO YOU ARE

You will thrive at KCAS Bio if you enjoy a relational environment, are purpose- and values-driven, embrace constant development and supportive leadership, and enjoy being part of innovative work.

WHAT YOU'LL GET

Our benefits include, and extend beyond, the traditional package. At KCAS Bio, you will enjoy company sponsored events like food trucks, family days and spirit days.You will grow in your career with KCAS University.You will be able to connect with like-minded employees to further KCAS Bio's approach to key areas such as wellness, inclusion, and community outreach.You will engage as an owner in our stock ownership program. You will have access to the latest technology. And you will be able to invest in the community with paid time off to volunteer.

Learn more about the Benefits at KCAS Bio

WHO WE ARE

We are a fast-growing contract research organization (CRO) headquartered in Kansas City, pioneering the latest drug development in both human and animal health fields.Demand for our expertise is growing and so is our need for great people to work in nimble, empowered teams committed to one another’s growth. At KCAS Bio, we advance both great science AND great people.

Learn more about what it is like to work at KCAS Bio

KCAS Bio is proud to be an Equal Opportunity Employer. Among other things, we provide equal employment opportunities without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, sex, sexual orientation, gender identity, or any other legally protected category; we recruit qualified candidates without regard to citizenship status based on internal processes that enable us to hire the right candidates consistent with the appropriate U.S. Immigration framework; and (3) we work with and provide reasonable accommodations to individuals with disabilities and for sincerely held religious beliefs, observances, and practices. Anyone who needs reasonable accommodation may send an email to [e-mail] or call 913-248-3000 (for TTY assistance call 711) and ask for Human Resources.

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