Quality Investigations Specialist III
Curia
Summary
The Quality Investigations Specialist III plays a critical role in ensuring the success of pharmaceutical manufacturing operations by providing Quality Assurance oversight and subject matter expertise for cGMP investigations. The specialist leads comprehensive root cause analyses of process deviations, non-conformances, and quality issues that may impact product safety, efficacy, or compliance, working closely with cross-functional teams to develop and implement corrective and preventive actions (CAPAs).
Job description
Essential Duties and Responsibilities
- Provides QA oversight 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
- Supports product complaints, deviations, and failure investigations
- Serves as the subject matter expert for all related analytical and technical Quality Assurance
- Reviews and closes Deviation investigations, Corrective and Preventative actions, and Change controls if related to investigations
- Reviews and supports root cause analysis process and determination of corrective actions stemming from investigations
- Identifies procedural deficiencies and proposes solutions to address
- Independently revises, reviews, and approves SOPs
- Provides guidance and mentorship to team members and junior staff
- Supports CURIA Compliance department during FDA and other agency inspections as well as customer and internal audits
- Understands Code of Federal Regulations European Medicines Agency Eudralex as they pertain to Pharmaceutical manufacturing for drug product
- Initiates and/or participates in the site or global projects and improvement efforts, as needed
- Read and Interpret SOPs to ensure compliance as Quality Assurance representative across Curia site
- Maintain up to date trainings
Education and Experience
- Bachelor's Degree in Science, Chemistry, Biology or related field of study
- Minimum of five (5) years of relevant 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
Other Skills and Abilities
- Provides guidance and mentorship to team members
- Fosters a collaborative and positive work environment
- Champions change
- Promotes a safe and healthy work environment
- Demonstrates strong attention to detail
Requirements
- Bachelor's Degree in Science, Chemistry, Biology or related field of study
- Minimum of five (5) years of relevant experience in 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
Benefits
- Generous benefit options
- Paid training
- Paid vacation
- Paid holidays
- Career advancement opportunities
- Education reimbursement
- 401(k) Matching
- Learning platform
Company overview
Curia is a leading global Contract Development and Manufacturing Organization (CDMO) with over 30 years of experience in the pharmaceutical industry. Headquartered in Albany, New York, the company operates an integrated network of 25 global sites across North America, Europe, and Asia, employing approximately 3,500 professionals. Curia provides comprehensive end-to-end solutions spanning drug discovery, development, and manufacturing services for both small molecules and biologics. Their expertise covers active pharmaceutical ingredient (API) manufacturing, sterile drug product development, analytical testing, and regulatory support. The company specializes in complex areas including high-potency compounds, controlled substances, sterile APIs, and mRNA manufacturing. With state-of-the-art GMP facilities and a strong focus on innovation, Curia partners with pharmaceutical and biotechnology companies to accelerate the development and commercialization of life-changing therapeutics, from early-stage discovery through commercial-scale production.