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 we get to do every day at KCAS Bio. If that gets you excited too, then maybe working at KCAS Bio is for you.
As a Quality Assurance Specialist II at KCAS Bio, you will be accountable for driving results in a fast-paced environment by effectively performing activities of some variety and complexity to ensure quality and compliance with applicable regulatory requirements. This will also include document review, audits, inspections, and consulting on quality and compliance issues.
In this role, we will rely on you for the following:
- Performs quality review and approval of documents, data, protocols, and/or reports
- Performs quality audits and/or inspections, preparing and distributing audit reports to study director, principal investigator, and/or management in a timely manner
- Reviews laboratory deviations and investigations
- Communicates with internal clients on open audits, deviations and/or investigations. o Follows up on outstanding audits, and related deviations and/or investigations
- Maintains accurate quality assurance files, records, and databases, and may generate metrics reports used to perform analysis and trending
- Provides training assistance in routine quality and compliance topics, for Quality Assurance group and/or other inter-company departments
- Assists with development/writing of quality SOPs, documents and/or reports as needed
- Provides consultation on quality and compliance topics in areas of expertise and assists with quality improvement initiatives as needed
- Assists with quality system continuous improvement activities
- May assist with client audits, where needed
- Follows and interprets instructions given; gathers clarification for thorough understanding of assigned tasks, including prioritization of tasks
- Demonstrates behaviors and attitude that is supportive of others in the department, as well as the organization
- Assists with providing solutions for issues
- Demonstrates client-focus by actions and follow through
To qualify specifically for this role, you will have:
- Bachelor's degree is preferred, but not required
- Experience with GLP, GCLP or GCP required
- Minimum 3 years of relevant Quality Assurance experience and/or related industry experience
- Exposure to and basic awareness of laboratory processes
(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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The Company
What We Do
With its presence in three locations across North America and Europe, KCAS Bio is a leading contract research organization (CRO) employing top scientific talent and providing comprehensive bioanalytical services to the global biopharmaceutical industry from early discovery support through product registration and beyond. The collaboration of the three entities allows for global support in bioanalytical, biomarker, immunogenicity, cellular and molecular assay services along with clinical kitting and sample management. The KCAS family of companies operates in state-of-the-art facilities in the United States and Europe. This business structure enables the expertise, capacity, and flexibility to support the development of all types of drugs, biologics, cell and gene therapies to improve health worldwide. Our purpose is to help accelerate the discovery and development of life-changing drugs smoothly, safely and sustainably.
