Quality Assurance Specialist II

About 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 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.

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

Additional information

(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.

Benefits

Learn more about the Benefits at Kcas Bio:

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