When you work as a QA Specialist I at KCAS, you get to further our mission by supporting quality assurance activities that help ensure our scientific work complies with applicable regulatory requirements, guidance documents, company policies, and procedures. You will build your knowledge of quality systems while performing document and data reviews, supporting audits and inspections, and working collaboratively with scientific and operational teams across the organization.
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 I, you will develop your understanding of our quality systems and regulatory environment while building the skills needed to grow within the Quality organization.
In this role, we will rely on you to:
- Perform Quality Assurance review and approval of documents, data, protocols, and reports
- Perform QA audits and inspections and prepare and distribute audit reports to Study Directors, Principal Investigators, and/or management in a timely manner
- Review deviations and investigations with guidance from more experienced Quality Assurance team members
- Maintain accurate Quality Assurance files, records, and databases and support data analysis and trending as needed
- Assist with the Quality Assurance review of Standard Operating Procedures (SOPs)
- Support Quality Assurance and quality system continuous improvement initiatives
- Demonstrate strong attention to detail when reviewing scientific documentation and data for accuracy, completeness, and compliance
- Gather clarification and ask appropriate questions to ensure a thorough understanding of assigned tasks and priorities
- Collaborate effectively with scientific, operational, and other cross-functional teams throughout the organization
- Demonstrate a client-focused approach through professional communication, responsiveness, and follow-through
- Assist with training activities related to routine Quality Assurance data review as needed
- Manage multiple assignments and priorities 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 related field
- At least 1 year of work experience in a professional environment
- Strong analytical skills and attention to detail, including basic math skills
- Good written and verbal communication skills with the ability to communicate effectively with internal and external clients
- Good organizational skills with the ability to manage multiple assignments and priorities
- Good computer skills and the ability to learn quality systems, databases, and other applicable software
- Ability to read, understand, and follow established procedures and requirements
- Ability to effectively collaborate with multiple levels and functions throughout the organization
- Ability to seek clarification, receive guidance, and apply feedback while developing greater independence in the role
- A commitment to quality, accuracy, accountability, and continuous improvement
Skills Required
- Bachelor's degree in a related field
- At least 1 year of work experience in a professional environment
- Strong analytical skills, attention to detail, and basic math skills
- Good written and verbal communication skills
- Ability to communicate effectively with internal and external clients
- Good organizational skills and ability to manage multiple assignments and priorities
- Good computer skills and ability to learn quality systems, databases, and applicable software
- Ability to read, understand, and follow established procedures and requirements
- Ability to collaborate effectively across multiple organizational levels and functions
- Ability to seek clarification, receive guidance, and apply feedback while developing independence
- Commitment to quality, accuracy, accountability, and continuous improvement
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.
