Quality Assurance Specialist II

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