Quality Assurance Specialist- Pharma Lab Production - Integris BioServices, LLC dba KCAS Bioanalytical and Biomarker Services

Performing critical work that impacts our industry and our world's health while problem solving and innovating in the field - at KCAS Bio that is what we get to do every day. If that gets you excited too, then maybe working in the Lab Support group at KCAS Bio is the spot for you.

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

The Quality Control Specialist in the Pharma Production Department acts as 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. The 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 quality assurance team.
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In this roll, we will rely on you to:

• Perform technical, scientific, and compliance reviews of data and documentation generated to support regulated GLP studies.
• Issue QC review observations and work closely with scientific staff to ensure data integrity.
• Collect metrics data to monitor the QC reviews and identify process improvements.
• Responsibly sign off on the data review (i.e., data summaries, report tables, manipulated transmittals 100% verification, verifies all outliers and repeated sample data.
• Review reports and documents and identify any deviations.
• Be proficient in lab software to review data (i.e., Watson).
• Proficient in LIMS and Quality Management software packages and capable of making minor changes in the software.
• Generate SOPs or policies in applicable areas as required.
• Archive data as needed.
• Perform other job duties as assigned by management.

To qualify for this roll, you will have:

• Bachelor's degree in chemical, biological science, or related field, with 5 years of related experience gained from working in biotech, pharmaceutical, CRO/CMO, or similar organizations and a combination of industry and research experience; or a Master's or Ph.D. with equivalent experience.
• Expert knowledge of data generated by the laboratory.
• Knowledge of GLP regulations
• Experience performing data review in a regulated environment and experience with relevant analytical methods such as UHPLC and LM/MS/MS.

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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.

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.

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.

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