Quality Assurance Specialist

Role Overview

• Provide quality oversight and support for quality systems, validation activities, aseptic processing programs, and regulatory compliance initiatives
• Author, review, and approve validation documentation
• Support continuous improvement of the Quality Management System (QMS)
• Ensure that all quality processes align with applicable regulatory requirements and industry standards
• Provide QA oversight of aseptic processing activities
• Participate in quality system activities, including deviations, investigations, CAPAs, change controls, and risk assessments
• Review quality records and documentation for completeness, accuracy, and compliance
• Support internal and external audits, inspections, and quality assessments
• Assist in the development, revision, and implementation of quality procedures and standards
• Collaborate cross-functionally to identify and implement quality and process improvements

Requirements

• Bachelor’s degree in Microbiology, Biology, Engineering, Pharmaceutical Sciences, or a related scientific discipline
• Minimum of 5 years of experience in Quality Assurance, Validation, or Quality Systems within a GMP-regulated pharmaceutical, biotechnology, or sterile manufacturing environment
• Demonstrated experience supporting aseptic manufacturing operations and contamination control programs
• Strong knowledge of:
• Aseptic process simulations (media fills)
• Environmental monitoring
• Sterilization validation
• Cleanroom operations
• Experience authoring and reviewing validation protocols, reports, investigations, risk assessments, and technical documentation
• Working knowledge of current GMP regulations and quality system requirements
• Strong technical writing, organizational, and analytical skills
• Ability to manage multiple priorities and meet deadlines

Benefits

• Competitive compensation based on experience