Quality Investigations Specialist II

About the role

The Quality Investigations Specialist plays a crucial role in ensuring that Curia's operations meet the highest standards of quality and compliance. Reporting to the Quality Manager, this individual will provide oversight and subject matter expertise for Good Manufacturing Practice (GMP) investigations, supporting the company's commitment to excellence.

Responsibilities

• Provides QA oversight and leads and subject matter expertise for GMP investigations
• Collaborates with Quality and Operations to ensure facilities and processes are ready for regulatory and customer inspections
• Supports product complaints, deviations, and failure investigations
• Contributes to CURIA’s core values of Curiosity, Urgency, Respect, Integrity, and Accountability
• Performs root cause analysis and implements corrective actions for process-related concerns
• Recommends and initiates changes to applicable Standard Operating Procedures (SOPs)
• Supports CURIA’s Compliance Department during FDA and other agency inspections and customer and internal audits
• Maintains a thorough understanding of government and industry quality assurance codes and standards
• Participates in site or global projects and improvement efforts
• Reads and interprets SOPs to ensure compliance
• Maintains up-to-date trainings
• Performs other duties as assigned

Requirements

• Provides guidance and mentorship to team members
• Fosters a collaborative and positive work environment
• 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

Qualifications

• Provides guidance and mentorship to team members
• Fosters a collaborative and positive work environment
• 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
• Education and Experience:
• 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
• Knowledge and Skills:
• Must know the US, European and Japanese Compendia requirements for a pharmaceutical facility and an analytical/microbiological laboratory
• Other Qualifications:
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Benefits

We offer a comprehensive benefits package including:

• 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
• 401(k) program
• Learning platform
• And more!