Quality Assurance Specialist - Harba Solutions : Job Details

Job Responsibilities

• Prepare and review supplier evaluation documentation, including evaluations, questionnaires, and audit reports.
• Manage supplier corrective action requests (SCARs) to ensure timely resolution and closure.
• Develop and oversee quality agreements with suppliers to align with organizational and regulatory standards.
• Conduct reviews of material specifications to ensure compliance with quality requirements.
• Plan and coordinate internal audits, including tracking of corrective and preventive actions.
• Provide support for external and third-party audits to ensure organizational readiness.
• Assist with recall and complaint management processes to address quality issues effectively.
• Contribute to the annual product review process by analyzing data and supporting compliance efforts.
• Perform regulatory surveillance and assessments using industry tools and platforms.
• Manage multiple high-priority projects in a dynamic and fast-paced environment.
• Provide flexible support during regular and after-business hours as needed.

Job Qualifications

• Bachelor's degree required (preferred fields: Chemistry, Biology, Biochemistry, Microbiology, or related sciences).
• Minimum of 5 years in a regulated pharma or life sciences industry, with a focus on supplier quality management or supply chain quality.
• At least 5 years of experience conducting internal audits.
• At least 2 years of experience managing recalls, complaints, and annual product reviews.
• Strong verbal and written communication skills, with the ability to convey complex information effectively.
• Proficiency in systems and software such as SAP, Word, Excel, Visio, JMP, and Minitab.
• Experience with supplier qualification activities for FDA or EMA-regulated manufacturing environments.
• Proven experience conducting audits of internal and external processes or facilities.
• Certified Quality Auditor or equivalent certification.