Quality Investigations Specialist III

Curia • Albuquerque, NM

1d

About The Position

The Quality Investigations Specialist III provides Quality Assurance oversight and subject matter expertise for current Good Manufacturing Practice (cGMP) investigations supporting pharmaceutical manufacturing operations. The role leads and supports root cause analysis of process deviations, non-conformances, product complaints, failures, and other quality issues that may affect product safety, efficacy, or regulatory compliance. It works with cross-functional teams, including production, engineering, validation, Quality, and Operations, to analyze information and develop corrective and preventive actions.

The specialist helps ensure investigations are closed in a timely manner, manufacturing processes and facilities remain inspection-ready, and operations comply with FDA and other regulatory requirements. The position also supports audits and regulatory inspections, reviews investigation-related deviations, CAPAs, and change controls, and contributes to continuous improvement initiatives. While the role has no formal supervisory responsibilities, it may provide mentoring, guidance, and advice to team members and junior staff.

Requirements

• Bachelor's degree in Science, Chemistry, Biology, or a related field.
• At least five years of relevant quality assurance and/or regulatory experience in the pharmaceutical industry.
• Demonstrated understanding of laboratory, manufacturing, packaging, regulatory, compliance, and quality assurance requirements for biological and drug-product manufacturing.
• Must pass a background check.
• Must pass a drug screen.
• May be required to pass occupational health screening.
• Demonstrates strong attention to detail.

Responsibilities

• Provide Quality Assurance oversight and subject matter expertise for GMP investigations.
• Work with Quality and Operations to maintain facilities and processes in a state of readiness for regulatory and customer inspections.
• Support product complaints, deviations, and failure investigations.
• Serve as a subject matter expert for related analytical and technical Quality Assurance.
• Review and close deviation investigations, corrective and preventive actions, and change controls related to investigations.
• Review and support root cause analysis and determine corrective actions arising from investigations.
• Identify procedural deficiencies and propose solutions.
• Independently revise, review, and approve standard operating procedures (SOPs).
• Provide guidance and mentorship to team members and junior staff.
• Support the Compliance department during FDA and other agency inspections, as well as customer and internal audits.
• Apply understanding of the Code of Federal Regulations and European Medicines Agency EudraLex requirements relevant to pharmaceutical drug-product manufacturing.
• Initiate or participate in site or global projects and improvement efforts as needed.
• Read and interpret SOPs to ensure compliance as a Quality Assurance representative across the Curia site.
• Maintain up-to-date training.
• Promote a safe and healthy work environment by identifying and addressing hazards, following safety protocols, participating in safety training, and fostering safety awareness.
• Contribute to Curia's values of Curiosity, Urgency, Respect, Integrity, and Accountability.
• Perform other duties as assigned.

Benefits

• Generous benefit options, eligible from the first day of employment.
• Paid training, vacation, and holidays; vacation accrual begins on the first day of employment.
• Career advancement opportunities.
• Education reimbursement.
• 401(k) program with matching contributions.
• Learning platform.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior