Quality Assurance Specialist 2

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