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.

Who You Are:

• 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.

GDH provides equal employment opportunities (EEO) to all employees and applicants for
employment without regard to race, color, religion, sex, national origin, age, disability, genetic
information, veteran's status or any other category protected by law. In addition to federal law
requirements, GDH Consulting, Inc. complies with applicable state and local laws governing
nondiscrimination in employment in every location in which the company has facilities and/or
employees. This policy applies to all terms and conditions of employment, including recruiting,
hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence,
compensation, benefits and training. Applicants with disabilities that require an accommodation
or assistance in applying and/or for interviewing, please contact our HR Department.

Please visit GDH's website for notice of collection for California applicants.