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Investigations Specialist - 1998131

Job Title: Quality Investigations Specialist

Location: Caguas, PR

Company Overview:

ProQuality Network is a leading Third-Party Consultants firm with insights into the world of investigation quality systems . We are committed to maintaining the highest quality standards in all aspects of our operations.

Position Overview:

We are seeking a highly motivated and detail-oriented Quality Investigations Specialist to join our team in Caguas, PR. The Quality Investigations Specialist will play a crucial role in ensuring compliance with regulatory requirements and driving continuous improvement in quality processes.


  1. Conduct thorough investigations into quality incidents, deviations, and non-conformances to determine root causes.
  2. Collaborate with cross-functional teams to implement corrective and preventive actions (CAPAs) to address quality issues.
  3. Maintain accurate documentation of investigations, findings, and corrective actions in accordance with regulatory standards.
  4. Participate in quality audits and inspections, providing support and expertise in investigation-related matters.
  5. Analyze data and trends to identify opportunities for process improvement and risk mitigation.
  6. Develop and deliver training programs related to investigation processes and quality compliance.
  7. Stay updated on industry trends, regulatory changes, and best practices in quality management.


  1. Bachelor's degree in Pharmacy, Chemistry, Biology, or related field. Advanced degree (e.g., Master's) is a plus.
  2. Minimum of 7 years of experience in quality assurance, quality control, or related roles within the pharmaceutical industry.
  3. Strong knowledge of cGMP (current Good Manufacturing Practices) regulations and quality management systems.
  4. Experience in conducting investigations, root cause analysis, and implementing CAPAs.
  5. Excellent analytical, problem-solving, and communication skills.
  6. Ability to work effectively in a fast-paced environment and collaborate with diverse teams.
  7. Proficiency in Microsoft Office Suite and quality management software (e.g., TrackWise) is preferred.

Application Process:

To apply for the Quality Investigations Specialist position, please submit your updated resume and a cover letter outlining your qualifications and interest in the role. Only shortlisted candidates will be contacted for further evaluation.

Join our team and contribute to our mission of delivering high-quality pharmaceutical products that improve patient outcomes!

Thank you. We will be in contact soon.

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