{"id":1641735,"url":"https://alion.io/job/elevatebio-lead-specialist-qa-validation-2","title":"Lead Specialist, QA Validation","company":{"id":3157164,"name":"ElevateBio","domain":"elevate.bio","url":"https://alion.io/company/elevate-bio","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"QA","role_family":"QA","seniority":"lead","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Waltham, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":50,"max":69,"currency":"USD","period":"hour","gross":null,"usd_annual":138000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-01T13:59:15Z","employer_posted_date":"2026-10-01","last_verified_at":"2026-10-13T18:48:26Z","board_verified":true,"closed_at":null,"days_open":12,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":12},"description":"ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.\nThe Role:\nElevateBio is looking for a Lead QAV Specialist to provide QA oversight for the BaseCamp Waltham Commissioning, Qualification, and Validation activities. In this role the Lead will be responsible for managing cGMP compliance from a Quality Assurance prospective of validation master plans, project validation plans, facility commissioning/qualification, utility commissioning/qualification, process equipment qualification, and lab equipment and instrument qualification. In addition, this position will support all risk assessments, technical reports, change controls, deviations and CAPAs related to commissioning, qualification, and validation activities. The candidate will contribute to team based collaborative environment promoting commitment to continuous improvement and achievement of goals within the QAV group.\n\nHere’s What You’ll Do:\nLeads QA partnership for operational activities for Engineering groups (i.e. commissioning, qualification, and validation activities to the GMP manufacturing facility and quality control laboratories). Recognized as quality expert for these programs and acts as direct escalation pathway for teams.\nLeads QA oversight of quality events for ongoing validation and engineering operations (equipment upgrades, deviations, and related CAPAs). Scope inclusive of manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.\nIndependently evaluates CQV change controls by authoring impact assessments and provides QA support and approval for associated CQV activities.\nLeads QA oversight for CMMS, collaborates with Engineering and Lab and Site Services to evaluate Quality impact for database modification requests.\nLiaise with project teams to develop project schedules, escalate issues, track milestones, and ensure adherence to program timelines.\nPotential to provide administration support for Kneat electronic validation system.\nLeads QA oversight and support for periodic review and requalification activities.\nManage team of QAV personnel including both FTE and contractor resources\nQA SME for Equipment Relocation program, supports all relocation activities that arise due to ongoing manufacturing needs.\n\nRequirements:\nBachelor’s degree and at least 5 years of related experience; or Master’s degree with at least 3 years of related experience; or a PhD with up to 1 year of related experience.\nStrong knowledge of 21 CFR, ICH, EU regulations\nPrior experience in Cell and Gene Therapy manufacturing a plus.\nPrior management experience a plus.\nExperience in new facility commissioning and qualification preferred.\nExperience with Blue Mountain CMMS system desired.\nStrong technical writing skills and proficiency in various computer programs (Word, Excel, PowerPoint, Kneat, Veeva, Blue Mountain CMMS)\nPossess a flexible approach to problem solving, be an adept negotiator and apply risk-based decisions.\nA team player, who listens effectively and invites response and discussion.\nA collaborator who communicates in an open, clear, complete, timely and consistent manner.\nPhysical and Environment Requirements:\nAbility to stand, walk, bend and stretch for extended period of time\nAbility to lift 15-20 lbs\nAbility to push, pull, bend, kneel, twist and climb step ladders while wearing PPE.\nAbility to perform routine repetitive motions with use of arms, wrists and hands\nThe budgeted range for this position is $50/hour - $69/hour. This range is a good faith estimate of the expected hourly range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law. \nElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.","description_format":"text","description_chars":4505,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":true,"industries":["Cell & Gene Therapy","CRO & CDMO Services"],"lifecycle":[{"event":"open","at":"2026-10-01T22:22:58Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.857,"p_room":1,"age_days":11,"expected_fill_days":34,"reasons":["conf:1","win:early"],"computed_at":"2026-10-13T05:45:00Z"},"pay":{"stated_usd_annual":138000,"is_top_pay":false},"html_url":"https://alion.io/job/elevatebio-lead-specialist-qa-validation-2","json_url":"https://alion.io/job/elevatebio-lead-specialist-qa-validation-2.json","meta":{"generated_at":"2026-10-13T20:24:54Z","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_verified","counted_by":"address","units_charged":1,"used_today":31395,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-14T00:00:00Z"}},"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":3157164},"rest":"https://alion.io/mcp/rest/get_company?id=3157164"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Felevatebio-lead-specialist-qa-validation-2"},{"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%2Felevatebio-lead-specialist-qa-validation-2"},{"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%2Felevatebio-lead-specialist-qa-validation-2"},{"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/elevatebio-lead-specialist-qa-validation-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Felevatebio-lead-specialist-qa-validation-2"}]}