The Quality Specialist I performs QA activities, document reviews, audits, and assists with quality improvements to ensure compliance with regulatory standards.
Summary Generated by Built In
Performing critical work that impacts our industry and our world’s health while problem solving and innovating in the field – that is what we get to do every day at KCAS Bio. If that gets you excited too, then maybe working at KCAS Bio is for you.
Performs activities of some variety and complexity to assure compliance with applicable regulatory requirements, guidance documents, related company policies and procedures, including document review, audits and inspections.
In this role, we will rely on you to:
• Performs QA review and approval of documents, data, protocols, and reports.
• Performs QA audits and/or inspections, preparing and distributing audit reports to the study director, principal investigator, and/or management in a timely manner.
• With guidance, reviews deviations and investigations.
• Maintains accurate quality assurance files, records, and databases, and may perform analysis and trending.
• May assist in QA review of SOPs.
• Assists with QA improvement initiatives.
• Demonstrates behaviors and attitudes that are supportive of others in the department, as well as the organization.
• Demonstrates client focus by actions and follow-through.
• Gathers clarification for a thorough understanding of assigned tasks, including prioritization of tasks.
• Assists with quality system continuous improvement, where needed.
• May provide training assistance for routine QA data review.
To qualify specifically for this role, you will have:
• 2 Years of Experience in industry related field preferred
• GLP/GCLP/GMP Laboratory experience preferred
(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 [email protected] or call 913-248-3000 (for TTY assistance call 711) and ask for Human Resources.
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