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.
Responsibilities:
- Conduct thorough investigations into quality incidents, deviations, and non-conformances to determine root causes.
- Collaborate with cross-functional teams to implement corrective and preventive actions (CAPAs) to address quality issues.
- Maintain accurate documentation of investigations, findings, and corrective actions in accordance with regulatory standards.
- Participate in quality audits and inspections, providing support and expertise in investigation-related matters.
- Analyze data and trends to identify opportunities for process improvement and risk mitigation.
- Develop and deliver training programs related to investigation processes and quality compliance.
- Stay updated on industry trends, regulatory changes, and best practices in quality management.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or related field. Advanced degree (e.g., Master's) is a plus.
- Minimum of 7 years of experience in quality assurance, quality control, or related roles within the pharmaceutical industry.
- Strong knowledge of cGMP (current Good Manufacturing Practices) regulations and quality management systems.
- Experience in conducting investigations, root cause analysis, and implementing CAPAs.
- Excellent analytical, problem-solving, and communication skills.
- Ability to work effectively in a fast-paced environment and collaborate with diverse teams.
- 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!