Quality Assurance Specialist

Essential Duties and Responsibilities:

• Support quality assurance activities within GMP/ISO regulated environments.
• Assist with investigations, root cause analysis, CAPA, and change control activities.
• Analyze quality data and implement corrective and preventive actions.
• Develop and maintain SOPs, protocols, reports, and quality documentation.
• Support quality systems and compliance initiatives.
• Collaborate cross-functionally to drive quality improvements and resolve issues.
• Utilize quality management systems and tools for tracking and reporting.
• Participate in quality metrics reporting and statistical analysis activities.
• Support project management initiatives and prioritize multiple assignments effectively.

Minimum Requirements:

• Bachelor’s degree plus 1 year of quality assurance experience in GMP/ISO regulated environments.
• Experience in medical devices, pharmaceuticals, or biotechnology preferred.
• Knowledge of cGMP regulations and ISO standards including ISO 13485 and ISO 9001.
• Experience with quality methodologies such as CAPA, risk management, root cause analysis, and change control.
• Strong documentation and technical writing skills.
• Experience with Microsoft Office Suite.

Preferred Qualifications:

• Degree in Life Sciences, Engineering, Chemistry, or related technical/scientific field.
• Experience with quality management software such as TrackWise or SAP QM.
• Experience with statistical analysis tools and quality metrics reporting.

Critical Skills Needed:

• GMP/ISO compliance
• CAPA and root cause analysis
• SOP and technical documentation
• Quality investigations
• Change control
• Analytical and problem-solving skills
• Cross-functional collaboration

Technical Skills:

• TrackWise
• SAP QM
• Microsoft Office Suite
• Statistical analysis tools
• Quality management systems

Education:

• Bachelor’s degree in Life Sciences, Engineering, Chemistry, or related scientific/technical field preferred.