Quality Assurance Investigations Analyst

1 week ago


Albuquerque, New Mexico, United States curiate Full time

Quality Assurance Investigations Analyst

Curia is a leading provider of global contract research and manufacturing services tailored for the pharmaceutical and biotechnology sectors.

The Quality Assurance Investigations Analyst plays a crucial role within the Curia team, ensuring our success through effective Quality Assurance oversight and specialized knowledge in current Good Manufacturing Practices (cGMP) investigations.

We take pride in our dedicated workforce, where excellence and a customer-centric approach are paramount. Our commitment to quality has the potential to enhance patients' lives through the pharmaceuticals we develop and produce.

We offer:

  • Comprehensive benefits starting from the first day of employment
  • Paid training, vacation, and holidays, with vacation accrual commencing immediately
  • Opportunities for career advancement
  • Education reimbursement programs
  • 401k retirement plan
  • Access to a learning platform
  • And additional perks

Supervisory Responsibilities:

This position does not include supervisory duties but may involve mentoring and advising team members.

Key Responsibilities:

  • Provide Quality Assurance oversight and lead investigations related to GMP
  • Collaborate with Quality and Operations teams to ensure facilities and processes are consistently prepared for regulatory and customer inspections
  • Work alongside Quality and Operations to guarantee timely and accurate execution of production tasks
  • Assist in addressing product complaints, deviations, and failure investigations
  • Serve as a subject matter expert for all analytical and technical Quality Assurance matters
  • Uphold Curia's core values of Curiosity, Urgency, Respect, Integrity, and Accountability
  • Review and resolve investigations and customer concerns
  • Conduct root cause analyses and implement corrective actions for process-related issues
  • Recommend and initiate updates to relevant Standard Operating Procedures (SOPs)
  • Support the Compliance department during inspections by regulatory agencies and audits
  • Maintain current knowledge of industry standards and government quality assurance regulations
  • Engage in site or global projects and improvement initiatives as necessary
  • Interpret SOPs to ensure compliance
  • Keep training up to date
  • Perform other duties as assigned

Required Qualifications:

  • Ability to guide and mentor team members
  • Foster a collaborative and positive workplace environment
  • Champion change initiatives
  • Promote a safe and healthy work environment by identifying and addressing potential hazards, adhering to safety protocols, and participating in safety training
  • Exhibit strong attention to detail

Education and Experience:

  • Bachelor's Degree in Science, Chemistry, Biology, or a related field is preferred
  • Associate's Degree in Science, Chemistry, Biology, or a related field
  • A minimum of three years of experience in quality assurance and/or regulatory roles within the Pharmaceutical industry, with a solid understanding of laboratory, manufacturing, packaging, regulatory compliance, and quality assurance standards for biological and drug product manufacturing
  • Familiarity with US, European, and Japanese Compendia requirements for pharmaceutical facilities and analytical/microbiological laboratories

Other Qualifications:

  • Successful completion of a background check
  • Pass a drug screening
  • May require passing Occupational Health Screening

Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.



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