Quality Investigations Specialist III

Curia • Albuquerque, NM

15h • Onsite

About The Position

The Quality Investigations Specialist III provides Quality Assurance oversight and subject matter expertise for current Good Manufacturing Practice (cGMP) investigations in pharmaceutical manufacturing. The role leads root cause analyses of process deviations, non-conformances, and other quality issues that may affect product safety, efficacy, or compliance. Working with cross-functional teams, including production, engineering, and validation, the specialist gathers and analyzes data and develops and implements corrective and preventive actions (CAPAs).

The specialist is responsible for timely investigation closure, compliance with FDA and other regulatory standards, and support for internal and external audits. The role also contributes to continuous improvement efforts to strengthen manufacturing processes and protect product quality and patient safety. It may involve mentoring and advising team members but does not have supervisory responsibilities.

Requirements

• Bachelor’s degree in Science, Chemistry, Biology, or a related field of study.
• 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.
• 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 matters.
• Review and close deviation investigations, corrective and preventive actions, and change controls related to investigations.
• Review and support root cause analysis and the determination of corrective actions stemming from investigations.
• Identify procedural deficiencies and propose solutions.
• Independently revise, review, and approve 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.
• Understand applicable Code of Federal Regulations and European Medicines Agency EudraLex requirements for 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 potential hazards, following safety protocols, participating in safety training, and fostering awareness and responsibility.
• Contribute to Curia’s core 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