Quality Assurance Specialist

Job Responsibilities:

• Review production activities, batch records, and completed forms for compliance with procedures and specifications.

• Oversee quality monitoring and testing activities, including environmental monitoring and product surveillance.

• Conduct inspections of materials and assess compliance through inspection reports, test records, and Device History Records.

• Support QA procedure updates, including writing, revising, training, and implementation.

• Compile and report quality metrics for daily, weekly, and monthly reporting.

• Collect and analyze information for Quality Management Reviews.

• Conduct CAPA investigations, propose corrective and preventive actions, and verify effectiveness.

• Initiate and investigate Nonconforming Material reports and present findings in periodic meetings.

• Train staff on QA review and release procedures.

• Participate in customer and regulatory audits/inspections, assisting with responses and corrective action plans.

Qualifications:

• 2-5 years of experience in Quality Assurance (QA), GMP, or other regulated industries

• Bachelor’s degree in Life Sciences, Engineering, or a related field (or equivalent experience)

• Strong attention to detail with experience in documentation review and compliance

• Solid understanding of GMP, CAPA, and regulatory requirements

• Proven ability to analyze data, compile reports, and identify trends

• Excellent communication, collaboration, and problem-solving skills