Job Summary:
The Quality Specialist ensures compliance throughout the investigation and reporting processes and manages GMP documentation review, approval, and archiving. This role supports quality metrics, data gathering, and various projects while strictly following Standard Operating Procedures (SOPs), maintaining required training, and upholding good documentation practices. The specialist reviews and approves batch records, non-conformances (NC), corrective and preventive actions (CAPAs), and change control records, and uses multiple GMP databases for data input, queries, and status management. The position requires a strong understanding of regulatory requirements, quality principles, and technical writing proficiency.

Key Responsibilities:

• Ensure investigations and reports comply with applicable regulations and company standards.
  

• Review, approve, and archive GMP documentation, including batch records, NCs, CAPAs, and Change Control records.
  

• Support the collection of metrics, data analysis, and project-based activities as needed.
  

• Adhere to and follow detailed Standard Operating Procedures (SOPs).
  

• Maintain current training records and perform good documentation practices for all controlled documents.
  

• Utilize databases for data entry, queries, managing statuses, and archiving documentation.
  

• Demonstrate comprehensive knowledge of regulatory requirements and quality principles.
  

• Provide assistance in compiling reports and technical documents for audits, inspections, and customer inquiries.
  

• Interact with customers as part of complaints investigation process and provide timely feedback and support.
  

• Collaborate with other departments to resolve quality issues and support continuous improvement efforts.

Qualifications:

• Bachelor’s degree in Sciences (Biology, Chemistry, or related field).
  

• 1–2 years of experience in complaints investigations, regulatory reporting, and customer interaction within a GMP-regulated environment.
  

• Experience with quality management systems, Microsoft Excel, and multiple GMP databases.
  

• Demonstrated technical writing skills and attention to detail.
  

• Strong understanding of GMP, regulatory requirements, and quality principles.
  

• Fully bilingual (Spanish and English), both written and verbal.
  

• Excellent organizational, time management, and problem-solving abilities.

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