Quality Investigations Specialist II

Quality Investigations SpecialistCuria 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.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 programLearning platformAnd more!This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.Responsibilities:Provides QA oversight/leads 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 inspectionsWorks with Quality and Operations to assure on-time and "right the first time" execution of production activitiesSupports product complaints, deviations, and failure investigations.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 investigations and customer concernsPerforms root cause analysis and implementation of corrective action for process-related concernsRecommends and initiates changes to applicable SOPsSupports CURIA Compliance department during FDA and other agency inspections as well as customer and internal auditsMaintains a working knowledge of government and industry quality assurance codes and standardsParticipates in the site or global projects and improvement efforts, as needed.Read/interpret SOPs to ensure complianceMaintain up to date trainingsOther duties as assignedRequired qualifications:Provides guidance and mentorship to team membersFosters a collaborative and positive work environmentChampions changeDemonstrates strong attention to detailEducation and Experience:Bachelor's Degree in Science, Chemistry, Biology or related field of study, preferredAssociate's Degree in Science, Chemistry, Biology or related field of studyMinimum 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 manufacturingMust know the US, European and Japanese Compendia requirements for a pharmaceutical facility and an analytical/microbiological laboratoryOther Qualifications:Must pass a background checkMust pass a drug screenMay be required to pass Occupational Health ScreeningEducation, experience, location and tenure may be considered along with internal equity when job offers are extended.All interested applicants must apply online. Please be aware of scammers. 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.