Quality Investigations Specialist III

Summary

Quality Investigations Specialist IIIBuild your future at Curia, where our work has the power to save livesCuria is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.We proudly offer:Generous benefit options (eligible first day of employment)Paid training, vacation and holidays (vacation accrual begins on first day of employment)Career advancement opportunitiesEducation reimbursement401K program with matching contributionsLearning platformAnd more!The Quality Investigations Specialist III plays a critical role in ensuring the success of our pharmaceutical manufacturing operations by providing Quality Assurance oversight and subject matter expertise for current Good Manufacturing Practice (cGMP) investigations. In this position, the specialist leads comprehensive root cause analyses of process deviations, non-conformances, and quality issues that may impact product safety, efficacy, or compliance. This position works closely with cross-functional teams such as production, engineering, and validation, to gather and analyzes data to develop and implement effective corrective and preventive actions (CAPAs). This role is responsible for ensuring timely investigation closure, maintaining compliance with FDA and other regulatory standards, and supporting internal and external audits. The Quality Investigations Specialist III also contributes to continuous improvement initiatives, helping to enhance the robustness of manufacturing processes and ensure the highest standards of product quality and patient safety.Essential Duties and Responsibilities:Provides QA oversight and subject matter expertise for GMP investigationsWorks with Quality and Operations to assure facilities and processes are in a constant state of readiness for regulatory and customer inspectionsSupports product complaints, deviations, and failure investigationsServes as the subject matter expert for all related analytical and technical Quality AssuranceContributes to CURIA's core values of Curiosity, Urgency, Respect, Integrity and AccountabilityReviews and closes Deviation investigations, Corrective and Preventative actions, and Change controls if related to investigationsReviews and supports root cause analysis process and determination of corrective actions stemming from investigationsIdentifies procedural deficiencies and proposes solutions to addressIndependently revises, reviews, and approves SOPsProvides guidance and mentorship to team members and junior staffSupports CURIA Compliance department during FDA and other agency inspections as well as customer and internal auditsUnderstands Code of Federal Regulations European Medicines Agency Eudralex as they pertain to Pharmaceutical manufacturing for drug productInitiates and/or participates in the site or global projects and improvement efforts, as neededRead and Interpret SOPs to ensure compliance as Quality Assurance representative across Curia siteMaintain up to date trainingsOther duties as assignedEducation and Experience:Bachelor's Degree in Science, Chemistry, Biology or related field of studyMinimum 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 manufacturingSupervisory Responsibilities: This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.Other Skills and Abilities:Provides guidance and mentorship to team membersFosters a collaborative and positive work environmentChampions changePromotes 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 membersDemonstrates strong attention to detailOther Qualifications: Must pass a background check, Must pass a drug screen, May be required to pass Occupational Health ScreeningEducation, experience, location and tenure may be considered along with internal equity when job offers are extended.Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. 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. Curia is an E-Verify employer.

Job Description

Quality Investigations Specialist IIIBuild your future at Curia, where our work has the power to save livesCuria is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.We proudly offer:Generous benefit options (eligible first day of employment)Paid training, vacation and holidays (vacation accrual begins on first day of employment)Career advancement opportunitiesEducation reimbursement401K program with matching contributionsLearning platformAnd more!The Quality Investigations Specialist III plays a critical role in ensuring the success of our pharmaceutical manufacturing operations by providing Quality Assurance oversight and subject matter expertise for current Good Manufacturing Practice (cGMP) investigations. In this position, the specialist leads comprehensive root cause analyses of process deviations, non-conformances, and quality issues that may impact product safety, efficacy, or compliance. This position works closely with cross-functional teams such as production, engineering, and validation, to gather and analyzes data to develop and implement effective corrective and preventive actions (CAPAs). This role is responsible for ensuring timely investigation closure, maintaining compliance with FDA and other regulatory standards, and supporting internal and external audits. The Quality Investigations Specialist III also contributes to continuous improvement initiatives, helping to enhance the robustness of manufacturing processes and ensure the highest standards of product quality and patient safety.Essential Duties and Responsibilities:Provides QA oversight and subject matter expertise for GMP investigationsWorks with Quality and Operations to assure facilities and processes are in a constant state of readiness for regulatory and customer inspectionsSupports product complaints, deviations, and failure investigationsServes as the subject matter expert for all related analytical and technical Quality AssuranceContributes to CURIA's core values of Curiosity, Urgency, Respect, Integrity and AccountabilityReviews and closes Deviation investigations, Corrective and Preventative actions, and Change controls if related to investigationsReviews and supports root cause analysis process and determination of corrective actions stemming from investigationsIdentifies procedural deficiencies and proposes solutions to addressIndependently revises, reviews, and approves SOPsProvides guidance and mentorship to team members and junior staffSupports CURIA Compliance department during FDA and other agency inspections as well as customer and internal auditsUnderstands Code of Federal Regulations European Medicines Agency Eudralex as they pertain to Pharmaceutical manufacturing for drug productInitiates and/or participates in the site or global projects and improvement efforts, as neededRead and Interpret SOPs to ensure compliance as Quality Assurance representative across Curia siteMaintain up to date trainingsOther duties as assignedEducation and Experience:Bachelor's Degree in Science, Chemistry, Biology or related field of studyMinimum 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 manufacturingSupervisory Responsibilities: This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.Other Skills and Abilities:Provides guidance and mentorship to team membersFosters a collaborative and positive work environmentChampions changePromotes 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 membersDemonstrates strong attention to detailOther Qualifications: Must pass a background check, Must pass a drug screen, May be required to pass Occupational Health ScreeningEducation, experience, location and tenure may be considered along with internal equity when job offers are extended.Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. 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. Curia is an E-Verify employer.