Quality Specialist - Intellectt INC

Location: South of Fairfax, VA

We are seeking an experienced Quality Specialist to enhance and oversee our Client's CAPA (Corrective and Preventive Actions) and NCR (Non-Conformance Reports) program. The ideal candidate will conduct thorough reviews of open records, facilitate investigations, and ensure the successful implementation and closure of CAPAs and NCRs.

• CAPA and NCR Review: Assess the current status of CAPA and NCR programs, identifying opportunities for improvement and ensuring compliance with industry standards.
• Investigation Facilitation: Develop work orders that streamline the investigation process, ensuring timely completion and effective resolution of open CAPAs and NCRs.
• Cross-Functional Collaboration: Work closely with various departments to address quality issues, implement corrective actions, and drive continuous improvement.
• Data Analysis: Utilize statistical techniques and data-driven problem-solving methods to support root cause investigations and risk management efforts.
• Reporting and Documentation: Maintain accurate records and documentation of investigations, findings, and actions taken to ensure transparency and accountability.

• Education: Bachelor's degree in Engineering or a related field.
• Experience:
  • Minimum of 5 years in the Pharmaceutical Industry, with hands-on experience in bulk mixing of solutions.
  • Minimum of 5 years as a Manufacturing Engineer focused on bulk mixing processes.
• Skills:
  • Strong understanding of manufacturing processes and quality control principles.
  • Proficient in statistical analysis and data-driven decision-making.
  • Demonstrated ability to conduct effective root cause investigations and implement corrective actions.
  • Excellent interpersonal and communication skills for cross-functional collaboration.

• Strong analytical and problem-solving abilities.
• Detail-oriented with a focus on quality and regulatory compliance.
• Proactive attitude and ability to work in a fast-paced environment.