{"id":3711968,"url":"https://alion.io/job/lumen-quality-assurance-associate-i","title":"Quality Assurance Associate I","company":{"id":11237,"name":"Lumen","domain":"lumen.bio","url":"https://alion.io/company/lumen","size_band":"11-50","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Seattle, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":65000,"max":70000,"currency":"USD","period":"year","gross":null,"usd_annual":70000},"salary_estimate":null,"experience_years_min":1,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"SharePoint","optional":false}],"status":"live","first_seen_at":"2026-11-03T18:52:22Z","employer_posted_date":"2026-11-03","last_verified_at":"2026-11-09T13:35:39Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"Quality Assurance Associate I at Lumen Bioscience\nLumen Bioscience is seeking a dedicated Quality Assurance (QA) Associate I to assist with maintaining our quality management system. This essential role supports compliance activities related to cGMP, cGLP, and cGCP (cGXP) standards, ensuring high-quality documentation, thorough reviews, and operational adherence to pharmaceutical regulations. If you have a keen eye for detail, excellent organizational skills, and a commitment to quality, we encourage you to apply.\nRole Description:\nDocumentation and Records: Perform document scanning and archival of controlled records, maintain accurate activity logs, and issue process documentation for manufacturing operations.\nOperational Support: Provide on-the-floor QA support to manufacturing operations, assisting in ensuring compliance with established cGXP processes.\nBatch Record Review: Conduct detailed reviews of batch records and related process documentation to uphold stringent quality standards.\nCompliance Walkthroughs: Regularly conduct facility and operational walkthroughs to verify compliance with the company's quality management system aligned with 21 CFR parts 210/211.\nQA Team Support: Assist the QA Manager and QA Specialist in various quality assurance tasks, including metric report preparation and quality event investigations.\nEssential Duties and Responsibilities:\nMaintain organized documentation through scanning, archiving, and record-keeping.\nIssue and review process documentation associated with manufacturing schedules.\nSupport on-the-floor quality assurance for manufacturing compliance.\nPerform facility walkthroughs to ensure adherence to pharmaceutical regulatory requirements.\nAssist with investigations and management of deviations, CAPAs, and other quality-related events.\nSupport internal and external audits, validation, qualification, and verification activities as needed.\nQualifications & Requirements:\nEducational Background: Associate's degree in a relevant scientific field, or at least 1 year of work experience in a regulated cGXP environment.\nTechnical Knowledge: Familiarity with cGMP, ISO 9001, and ICH requirements related to document control and quality records.\nTechnical Skills: High proficiency in Microsoft Word, Excel, and SharePoint.\nPersonal Attributes: Strong organizational skills, detail-oriented, ability to multitask, excellent communication skills, adaptability, and commitment to quality and ethical standards.\nPhysical Requirements:\nAbility to sit and stand for extended periods (2+ hours each).\nOccasionally lift or carry items up to 20 kg.\nSalary & Benefits at Lumen Bioscience:\n$65,000 - $70,000 annually \nHealth, Dental, and Vision premiums fully covered by Lumen.\n401k match up to 4%, in addition to annual stock bonuses for all employees.\nIndustry-leading PTO policy, paid refresh days, and year-end holiday office closure.\nMonthly wellness programs to support employee health.\nFree onsite parking or public transportation subsidies.\nComprehensive parental leave.\nLife insurance, short & long-term disability, and employee assistance programs.\nAt Lumen Bioscience, we foster a collaborative and innovative work environment where your contributions directly impact biotechnology and global health solutions.\nJoin us and play a vital role in maintaining exceptional quality standards and regulatory compliance.\nCompensation Range\n$65,000—$70,000 USD","description_format":"text","description_chars":3422,"description_truncated":false,"requirements":{"experience_years_min":1,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"associate","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Life insurance","Parental leave","Wellness"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology"],"lifecycle":[{"event":"open","at":"2026-11-03T23:40:27Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 1","filings_12m":1,"filings_prev_12m":0,"green_card_filings_12m":0,"median_offered_wage_usd":57500,"route":null,"cap_exempt":false,"checked_at":"2026-11-09T07:32:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":84,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.843,"p_room":1,"age_days":5,"expected_fill_days":23,"reasons":["conf:1","win:early","comp:junior"],"computed_at":"2026-11-09T06:03:00Z"},"pay":{"stated_usd_annual":70000,"is_top_pay":false},"html_url":"https://alion.io/job/lumen-quality-assurance-associate-i","json_url":"https://alion.io/job/lumen-quality-assurance-associate-i.json","meta":{"generated_at":"2026-11-09T16:23:22Z","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":23760,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-10T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":11237},"rest":"https://alion.io/mcp/rest/get_company?id=11237"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Flumen-quality-assurance-associate-i"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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%2Flumen-quality-assurance-associate-i"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Flumen-quality-assurance-associate-i"},{"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/lumen-quality-assurance-associate-i\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Flumen-quality-assurance-associate-i"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3711968}},{"tool":"search_jobs","arguments":{"company":"lumen.bio","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3711968},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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