QA Specialist

• Support quality assurance activities to help ensure scientific work complies with applicable regulatory requirements, guidance documents, company policies, and procedures
• Perform Quality Assurance review and approval of documents, data, protocols, and reports
• Perform QA audits and inspections and prepare and distribute audit reports
• Review deviations and investigations with guidance from experienced Quality Assurance team members
• Maintain accurate Quality Assurance files, records, and databases and support data analysis and trending
• Assist with Quality Assurance review of Standard Operating Procedures (SOPs)
• Support quality system continuous improvement initiatives
• Review scientific documentation and data for accuracy, completeness, and compliance
• Collaborate with scientific, operational, and cross-functional teams
• Assist with training activities related to routine Quality Assurance data review
• Manage multiple assignments and priorities while meeting established timelines

• 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
• Commitment to quality, accuracy, accountability, and continuous improvement

Demonstrates expertise in Quality Assurance processes, including document review, audits, and compliance with regulatory requirements. Proficient in data analysis, collaboration with cross-functional teams, and continuous improvement initiatives.

• Quality Assurance Review
• Regulatory Compliance
• Data Analysis
• Document Review
• Audit Preparation

• Quality Assurance
• Data Analysis
• Document Review
• Audit Inspection
• Standard Operating Procedures (SOPs)
• Quality Systems
• Basic Math Skills

• Analytical Skills
• Attention to Detail
• Written Communication
• Verbal Communication
• Organizational Skills

• Quality Assurance
• Regulatory Requirements
• Continuous Improvement
• Scientific Documentation
• Cross-Functional Collaboration

• Databases
• Quality Systems Software