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Senior Quality Investigator
3 months ago
Are you ready to lead and innovate in a dynamic environment?
STAQ Pharma is seeking an experienced Senior Quality Investigator to join our team in Denver. We are looking for individuals with 8-10 years of experience in the biopharma industry who are passionate about quality and continuous improvement.
Pay: $90K-110K/year
What You’ll Do:
- Lead Investigations: Independently drive and oversee the deviation and investigation process to closure, ensuring thorough root cause analysis using tools like Control Charts, Fishbone Diagrams, 6Ms, and 5 Whys.
- Implement CAPAs: Develop and execute robust Corrective and Preventive Actions (CAPAs) to prevent recurrence of deviations.
- Monitor and Improve: Track deviation metrics, identify trends, and initiate continuous improvement projects.
- Manage Deviations: Ensure Right First Time (RFT) and timely completion of deviation phases.
- Collaborate Cross-Functionally: Work with various departments to address deviations effectively and promptly.
- Educate and Train: Create preventive measures, conduct training sessions, and act as the SME and Trainer for the Investigation/CAPA QMS module.
- Audit Participation: Actively participate in internal and external audits as an SME for deviations.
- Document Management: Review and approve change controls, SOPs, and other GMP documents.
Requirements:
- Educational Background: Bachelor’s degree in Engineering, Chemistry, Biology, or a related scientific discipline. An advanced degree is preferred.
- Industry Experience: Minimum of 8-10 years in pharmaceutical manufacturing and quality management systems, with hands-on experience in conducting investigations and root cause analysis.
- Technical Skills: Proficiency with electronic quality management systems (MasterControl) and advanced knowledge of cGMP regulations.
- Leadership and Collaboration: Strong leadership skills, ability to resolve conflicts, meet deadlines, and work collaboratively.
- Communication Skills: Excellent verbal and written communication abilities.
- Problem-Solving: Strong critical thinking skills to address complex issues.
- Adaptability: Ability to manage multiple projects and adapt to changing priorities.
- Technical Proficiency: Skilled in using Microsoft Applications, including MS Word, Excel, and Teams.
Join us at STAQ Pharma and contribute to our mission of maintaining the highest quality standards. Apply now to be part of a team that values innovation, collaboration, and continuous improvement.
