Data Reviewer Sr. Analyst- BioPharma LBA - Integris BioServices, LLC dba KCAS Bioanalytical and Biomarker Services
Olathe, KS 66051
About the Job
As a Data Reviewer Specialist on the KCAS BioPharma LBA group, you will be a contributing specialist for studies, with the ability to carry out aspects of data review, expediting audit responses, and reporting (data reviewing with minimal guidance) through report finalization.
T he Data Reviewer Specialist has excellent organizational skills and utilizes a strong base in regulatory policy to assess data review and reporting and maintains a high level of professional interaction - both inter and intra-department.
As an advocate and trusted advisor, this role can influence others while performing technical reviews of raw and processed data, ensuring data integrity standards are met across various equipment, regulatory settings, and workflows while also serving as a connector between the lab and the quality assurance team.
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In this role, we will rely on you to:
- Responsibly sign off on the data (i.e., 100% Excel spreadsheet review, report tables, manipulated transmittals 100% verification, verifies all outliers and repeated samples (i.e., positive predose, placebo, etc).
- Review reports and documents accordingly.
- Be proficient in lab software in order to review data (i.e. Analyst and Watson).
- Be capable of making minor changes in LIMs software.
- Generate SOPs or policies in applicable areas as required.
- Archive data as needed.
- Perform other job duties as assigned by management.
To qualify specifically for this role, you will have:
- Bachelor of Science (BS)
- 3 years of related experience gained from research or industry.
- Expert knowledge of data generated in a GLP laboratory.
- Thorough understanding of regulatory policy compliance.
- Familiarity with current industry trends and expectations.
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(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.
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.
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 kcasrecruiting@kcasbio.com or call 913-248-3000 (for TTY assistance call 711) and ask for Human Resources.