{"id":1914351,"url":"https://alion.io/job/probio-cdmo-expert-qa-technical-operations","title":"Expert - QA Technical Operations","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":3,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-08T05:49:30Z"}},"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":95000,"currency":"USD","period":"year","gross":null,"usd_annual":95000},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-05T13:21:36Z","employer_posted_date":"2026-10-05","last_verified_at":"2026-10-08T20:25:55Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"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.\nThe Expert of QA Technical Operations will be responsible for:\nInterpreting, building upon, and complying with company quality assurance standards\nManaging daily supplier quality activities and controls\nSupporting the Strategic Supplier Management process to meet quality, delivery, and cost objectives\nDeveloping and executing strategic plans to improve supplier quality, delivery, and costs\nOverseeing inbound material release process\nChampion quality assurance procedures, tools, and techniques\nRoles and Responsibilities\nAuthor/Review SOPs\nOversee the GMP supplier qualification program and supplier risk management\nCompletes the approval requirements to qualify new suppliers including negotiating quality agreements, as well as audit scheduling, conduction of audits, and authoring of audit reports\nPeriodic review of suppliers and identification of supplier compliance issues\nManages vendor complaints\nParticipates in or manages quality assessments of internal operations and suppliers to analyze compliance and assess risk\nLiaison between Supplier and QA representatives in addressing the quality concerns from the supply chain\nMonitor supplier non-conformance performance, and drive root-cause analyses, corrective actions & process improvements to reduce the Number of Defects & Cost of Quality\nEnsures effective and timely investigation and closure of all CAPAs, supplier non conformances, complaints, and product issues\nDevelopment and maintenance of measurement systems for quality costs, indicators, trends and supplier rating\nCollects data and compiling supplier scorecards\nManages audit schedule and executes supplier audits\nGenerates specifications for materials and consumables\nResponsible for disposition of materials and consumables\nApprove calibration reports for GMP equipment\nSupport QA Validation in review of SOPs\nMay interface with auditors during regulatory inspections\nWorks closely with Facilities, QA Validation, Manufacturing, and QC teams\nTravel expectations: < 10%\nQualifications\nBachelor's degree in science, Engineering, Business, Management or related field (Advance degree a plus)\n3-5+ years of experience in Quality, Manufacturing, Engineering, or related field\nResults oriented, driven individual\nExcellent interpersonal, communication and negotiation skills\nStrong organizational and problem-solving abilities\nHigh attention to detail and accuracy\nAbility to work collaboratively in a team environment\nThe estimated pay range for the role is between $70,000 - $95,000 based on qualifications 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. Probio does not request personal information from candidates through individual email or any other platform.","description_format":"text","description_chars":4885,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Parental leave","Retirement plans","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Cell & Gene Therapy"],"lifecycle":[{"event":"open","at":"2026-10-05T15:43:57Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":2,"expected_fill_days":23,"reasons":["conf:1","win:early"],"computed_at":"2026-10-08T05:49:30Z"},"pay":{"stated_usd_annual":95000,"is_top_pay":false},"html_url":"https://alion.io/job/probio-cdmo-expert-qa-technical-operations","json_url":"https://alion.io/job/probio-cdmo-expert-qa-technical-operations.json","meta":{"generated_at":"2026-10-09T00:06:13Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":36,"day_limit":5000,"remaining_today":4964,"minute_limit":60,"resets_at":"2026-10-10T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":2125529},"rest":"https://alion.io/mcp/rest/get_company?id=2125529"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fprobio-cdmo-expert-qa-technical-operations"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fprobio-cdmo-expert-qa-technical-operations"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fprobio-cdmo-expert-qa-technical-operations"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/probio-cdmo-expert-qa-technical-operations\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fprobio-cdmo-expert-qa-technical-operations"}]}