Quality Assurance Specialist II
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- United States
- Work type
- Hybrid
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Performing critical work that impacts our industry and our world’s health while problem solving and innovating in the field – that is what a Quality Assurance Specialist II at KCAS Bio gets to do every day. If that gets you excited too, then maybe working as an Quality Assurance Specialist II at KCAS Bio is the role for you.
When you work as a QA Specialist II at KCAS, you get to further our mission by independently performing quality assurance activities that help ensure our scientific work complies with applicable regulatory requirements, guidance documents, company policies, and procedures. You will apply your knowledge of quality systems and regulatory requirements to perform document and data reviews, conduct audits and inspections, support investigations, and partner with scientific and operational teams to maintain the quality and integrity of our work.
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 II, you will work with increasing independence while serving as a quality resource to teams throughout the organization.In this role, we will rely on you to:
- Independently perform Quality Assurance review and approval of documents, data, protocols, reports, and other study-related documentation for accuracy, completeness, and compliance
- Conduct QA audits and inspections and prepare and communicate findings to Study Directors, Principal Investigators, management, and other appropriate stakeholders
- Review deviations, investigations, corrective and preventive actions, and other quality events and provide guidance regarding applicable quality and regulatory requirements
- Review SOPs and other controlled documents and support the development and continuous improvement of Quality Assurance processes and quality systems
- Maintain accurate QA files, records, databases, and trending information and identify potential quality or compliance trends requiring additional review
- Partner with scientific and operational teams to resolve quality and compliance issues while maintaining a professional, collaborative, and client-focused approach
- Support audit and inspection readiness and participate in client, internal, and regulatory inspections as appropriate
- Provide guidance and training to less experienced team members on routine QA activities, quality systems, and applicable procedures
- Manage multiple audits, reviews, and assignments independently 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
To qualify specifically for this role, you will have:
- Bachelor’s degree in a scientific, quality, or related field
- At least 2–3 years of relevant Quality Assurance, regulated laboratory, pharmaceutical, biotechnology, CRO, or related experience
- Working knowledge of GLP and applicable regulatory requirements, guidance documents, and quality systems
- Experience reviewing scientific documentation, data, protocols, reports, or other regulated records for accuracy and compliance
- Experience conducting or supporting quality audits and inspections
- Experience reviewing deviations, investigations, CAPAs, or other quality events
- Strong analytical skills and attention to detail with the ability to identify quality or compliance concerns
- Strong written and verbal communication skills with the ability to communicate findings clearly and professionally
- Strong organizational skills with the ability to independently manage multiple assignments, audits, and priorities
- Ability to interpret and apply SOPs, regulatory requirements, and established quality procedures
- Ability to effectively collaborate with scientific, operational, and other cross-functional teams
- Strong computer skills with the ability to work effectively with quality systems, databases, and other applicable software
- A demonstrated commitment to quality, data integrity, accountability, and continuous improvement
Preferred Qualifications:
- Quality Assurance experience within a CRO, pharmaceutical, biotechnology, or bioanalytical laboratory environment
- Experience supporting GLP-regulated bioanalytical studies
- Experience participating in client or regulatory audits and inspections
- Experience providing training or guidance to less experienced Quality Assurance staff
(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.
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