Quality Assurance Specialist

Job Description:
Our client is seeking a detail-oriented and motivated Quality Assurance (QA) Specialist to join their team in a GMP-regulated environment. The QA Specialist will play a vital role in ensuring that all products meet the highest standards of quality, safety, and regulatory compliance in accordance with Good Manufacturing Practices (GMP). The ideal candidate will have a strong background in quality assurance, a deep understanding of GMP guidelines, and the ability to collaborate effectively with cross-functional teams to ensure that processes and products meet both internal standards and regulatory requirements.

What You Will Do:

• Collaborate with department management on investigations and develop strategies to prevent future quality deviations.
• Lead, initiate, track, and trend investigations related to customer product complaints.
• Verify the accuracy of reported complaints and make corrections before triaging customer product complaints.
• Provide customer support and resolve inquiries related to product complaints via phone or email.
• Assist subject matter experts in conducting root cause analysis.
• Utilize technical writing strategies to ensure investigative reports are clear, concise, and complete.
• Report potential quality issues that may impact product quality or regulatory compliance to Quality Management.
• Compile and maintain quality performance metrics, analyzing trends for continuous improvement.
• Create, update, and review Standard Operating Procedures (SOPs) in compliance with GMP regulations.
• Assist MasterControl Sysadmins with troubleshooting issues and process improvements.
• Conduct internal audits to assess compliance with regulatory and quality requirements.
• Support external audits conducted by regulatory agencies, providing necessary documentation.
• Ensure all equipment is calibrated on schedule and in compliance with GMP regulations.
• Review and approve calibration certificates and maintenance records to verify equipment functionality.
• Perform other duties as assigned.

• Bachelor’s degree in a relevant field.
• Minimum 5 years of experience in investigations, root cause analysis, and CAPA execution in an FDA-regulated environment.
• Proficiency in root cause analysis tools and investigative methodologies.
• Strong knowledge of GMP, ICH guidelines, pharmaceutical compendia, and FDA regulations.
• Excellent critical thinking, analytical reasoning, and problem-solving skills.
• Strong technical writing skills for SOPs and investigative reports.
• Strong communication and customer service skills.
• Experience generating and interpreting quality metrics.
• Ability to thrive in a fast-paced environment while meeting productivity demands.
• Effective time management skills to meet deadlines and manage workload.
• Ability to present issues and trends in clear, technical language.
• Experience with electronic quality management systems.
• Experience conducting internal audits and participating in regulatory inspections is a plus.