Quality Deviation Investigator III

Quality Deviation Investigator III in Albuquerque, NM

 

Summary: 

 

The Quality Deviation Investigator III plays a crucial role in overseeing and executing highly complex, regulatory-compliant investigations, ensuring exceptional technical accuracy and thoroughness in all reporting. In this senior-level position, the Investigator collaborates with cross-functional teams to collect and analyze critical data on manufacturing and laboratory deviations, leading advanced root cause analysis sessions with subject matter experts to identify underlying systemic issues. The Investigator III develops and implements comprehensive corrective and preventive actions (CAPAs) that address both immediate and long-term quality risks, promoting continuous improvement and operational excellence. As an expert within the Quality Assurance Investigations team, this role drives a culture of quality and compliance across the organization, advising senior leadership on strategic improvements, and ensuring alignment with industry standards and regulatory expectations.

We proudly offer

• Generous benefit options (eligible first day of employment) 
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities 
• Education reimbursement
• 401k program
• Learning platform
• And more! 

Essential Duties and Responsibilities:

• Manage complex investigations into manufacturing and laboratory deviations, ensuring strict regulatory compliance, technical accuracy, and timely documentation of findings. 
• Collaborate with cross-functional teams, including Operations, Quality Control, and Engineering, to assess scope, product impact, and ensure comprehensive investigation results. 
• Facilitate root cause analysis sessions with subject matter experts, identifying the underlying causes of deviations and developing corrective and preventive actions (CAPAs) to prevent recurrence.
• Ensure effective implementation and monitoring of CAPAs to maintain high-quality standards.
  Contribute to the enhancement of GMP policies, SOPs, and quality management systems.
• Identify and implement process improvements to drive operational efficiency, minimize risks, and eliminate non-value-added activities.
• Ensure the timely update of SOPs and other critical documentation.
• Mentor and train team members to reinforce a culture of quality, compliance, and continuous improvement. Foster a positive, equitable work environment aligned with Curia’s values:
• Curiosity, Urgency, Respect, Integrity, and Accountability.
• Lead by example to promote quality excellence across the organization, ensuring that investigation findings, CAPAs, and corrective actions support the company's commitment to
• regulatory compliance and operational success.
• Read/interpret SOPs to ensure compliance
• Maintain up to date trainings
• Other duties as assigned

 

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture. 

 

Education and Experience:

• Bachelor’s Degree in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy, or related field of study or 4 years of relevant experience
• Minimum of five (5) years’ related quality deviation experience 
• Experience with deviation or investigation management systems 
• Experience in a cGMP-regulated manufacturing Pharmaceutical, Biotechnology and/or QA/QC, required 
• Technical writing experience, writing deviations and CAPAs in the pharmaceutical/biotech environment, or related industry, required 
• Proficient in Deviation Management (i.e., TrackWise), preferred 
• Experienced in troubleshooting, investigation, and root-cause analysis in a cGMP environment 

 

Supervisory Responsibilities:                                                            

This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.

 

Language Skills:                                                        

The ideal candidate should have the ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, they should possess strong written and verbal communication skills, along with effective presenta