Quality Investigations Specialist II

Curia • Albuquerque, NM

10d • Onsite

About The Position

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. The Quality Investigations Specialist is an integral part of the Curia team, contributing to our success by providing Quality Assurance oversight and subject matter expertise for current Good Manufacturing Process (cGMP) investigations. 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.

Requirements

• Provides guidance and mentorship to team members
• Fosters a collaborative and positive work environment
• Champions change
• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.
• Demonstrates strong attention to detail
• Bachelor’s Degree in Science, Chemistry, Biology or related field of study, preferred
• Associate’s Degree in Science, Chemistry, Biology or related field of study
• Minimum of three (3) years of experience in quality assurance and/or regulatory experience in the Pharmaceutical industry with demonstrated understanding of laboratory, manufacturing, packaging, regulatory, compliance, and quality assurance requirements for biological and drug product manufacturing
• Must know the US, European and Japanese Compendia requirements for a pharmaceutical facility and an analytical/microbiological laboratory
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Responsibilities

• Provides QA oversight/leads and subject matter expertise for GMP investigations
• Works with Quality and Operations to assure facilities and processes are in a constant state of readiness for regulatory and customer inspections
• Works with Quality and Operations to assure on-time and “right the first time” execution of production activities
• Supports product complaints, deviations, and failure investigations.
• Subject matter expert for all related analytical and technical Quality Assurance
• Contributes to CURIA’s core values of Curiosity, Urgency, Respect, Integrity and Accountability
• Reviews and closes investigations and customer concerns
• Performs root cause analysis and implementation of corrective action for process-related concerns
• Recommends and initiates changes to applicable SOPs
• Supports CURIA Compliance department during FDA and other agency inspections as well as customer and internal audits
• Maintains a working knowledge of government and industry quality assurance codes and standards
• Participates in the site or global projects and improvement efforts, as needed.
• Read/interpret SOPs to ensure compliance
• Maintain up to date trainings
• Other duties as assigned

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree