{"id":1814955,"url":"https://alion.io/job/probio-cdmo-sr-specialist-quality-systems","title":"Sr. Specialist, Quality Systems","company":{"id":2125529,"name":"ProBio CDMO","domain":"probiocdmo.com","url":"https://alion.io/company/probiocdmo","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"B","score":75,"open_postings":4,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-14T06:34:16Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Pennington, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":70000,"max":90000,"currency":"USD","period":"year","gross":null,"usd_annual":90000},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-24T13:22:43Z","employer_posted_date":"2026-09-30","last_verified_at":"2026-10-15T02:44:07Z","board_verified":true,"closed_at":null,"days_open":20,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":20},"description":"ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017.\nAbout the job:\nContributes to the administration, maintenance, and continuous improvement of ProBio’s Quality Management System (QMS) to ensure compliance with applicable GMP regulations, industry standards, and company procedures for both clinical and commercial Cell and Gene Therapy products. This role supports quality system processes including deviations, lab investigations, Corrective and Preventative Actions (CAPA), change controls, complaints, risk management, training, document control, management review, and regulatory inspection readiness.\nThe position collaborates cross-functionally with internal teams, customers, and external resources (when required) to ensure compliance and drive a culture of quality and operational excellence. \nResponsibilities:\nQuality Management System (QMS)\nMaintain and continuously improve ProBio Inc. and external Quality Management Systems ensuring GxP compliance with worldwide manufacturing regulations, guidelines, and current regulatory requirements for both clinical and commercial Cell and Gene Therapy products manufactured and/or tested at the Hopewell, NJ facility.\nManage and perform Quality Assurance (QA) review and approval of documentation related to Change Control, Corrective and Preventative Action (CAPA), Deviations, Laboratory Investigations, incidents, complaints, exceptions, and Out of Specification (OOS) reports as generated by ProBio Hopewell, NJ facility in accordance with current QA procedures.\nFacilitate and support ProBio internal team members with Root Cause Analysis and Investigations using established methodologies. Drives completion of Investigations and ensures timely implementation and effectiveness verification of CAPAs as needed.\nMonitor quality system performance and overdue actions.\nSupport development, implementation, and monitoring of quality metrics and Key Performance Indicators (KPIs).\nAnalyze quality trends and generate quality management review reports. Recommend and implement process improvements to enhance effectiveness and compliance.\nInspection and Audit Support\nParticipate in customer audits, regulatory inspections, and internal audits.\nCoordinate responses to audit observations and inspection findings.\nMaintain inspection readiness at all times.\nPerforms other tasks and assignments as needed and specified by management.\nQualifications:\nBachelor’s degree in a scientific discipline with 3+ years of experience in QA or related role(s) in a pharmaceutical, biotechnology or related environment.\nDemonstrated experience with GxP document management systems and/or other QMS (e.g. Veeva QualityDocs, Veeva QMS, TrackWise QMS etc.).\nDemonstrated knowledge and understanding of business practices and procedures associated with GxP Document Control, Change Control, CAPA, Deviation and/or Lab investigations.\nIn-depth knowledge of quality risk management, Root Cause Analysis, and appropriate investigation tools.\nDemonstrated understanding biologics manufacturing and laboratory activities.\nDetailed knowledge and understanding of GMP regulations and compliance regulatoryrequirements.\n\nDemonstrated ability to communicate proactively with a positive customer service attitude.\nProficiency with Microsoft Office.\nExcellent verbal and written communication skills.\nAbility to work virtually, independently, and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.\nAnalytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.\nExcellent planning, organization and time management skills including the ability to support and prioritize multiple projects.\nPay range is estimated between $70k - $90k based on skill set and experience.\nBenefits:\nBenefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.\nProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.\nProBio Inc. maintains a drug-free workplace.\nPlease note: ProBio Inc. will only contact candidates through verified application sources. 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