{"id":1346919,"url":"https://alion.io/job/thorne-quality-assurance-capa-specialist","title":"Quality Assurance CAPA Specialist","company":{"id":1769319,"name":"Thorne","domain":"thorne.com","url":"https://alion.io/company/thorne-com","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Pinpoint","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Summerville, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":79000,"max_usd":150000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":6333},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-09-26T17:07:12Z","employer_posted_date":"2026-10-20","last_verified_at":"2026-11-01T11:35:33Z","board_verified":true,"closed_at":null,"days_open":35,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":35},"description":"At Thorne, we work to deliver high-quality, science-backed solutions to empower individuals to take a proactive approach to their well-being. Each day begins with a mission to help others discover and achieve their best health. We count on our team members to challenge and push the boundaries to make that happen. At Thorne, you’ll be joining a team of more than 750 passionate individuals committed to our cause of providing superior health solutions at every age and life stage.\n The Quality Assurance (QA) CAPA Specialist is responsible and accountable for the execution, governance, and effectiveness of Thorne’s Corrective and Preventive Action (CAPA) program across internal manufacturing operations, Outside Contract Manufacturers (OCMs), and external suppliers.\n\nThis role serves as the CAPA subject matter expert and program coordinator within the Quality organization and is responsible for driving quality events to effective and sustainable resolution. The QA CAPA Specialist ensures CAPAs are initiated, investigated, implemented, tracked, and closed in a timely and compliant manner, and partners closely with Manufacturing, QC, Engineering, Supplier Qualification, Procurement, and external partners.\n\nThis role requires strong working knowledge of cGMP quality systems, structured root cause analysis, project management, and very strong communication skills to drive accountability across departments and external partners without direct authority.\nRESPONSIBILITIES\nCoordinates and governs Thorne’s CAPA process, ensuring compliance with internal procedures, cGMP requirements, and regulatory expectations.\nServes as the CAPA subject matter expert and primary contact for process guidance, training, and continuous improvement.Ensures CAPAs are appropriately initiated from deviations, investigations, audits, complaints, OOS, supplier issues, and OCM quality events.\nFacilitates CAPA meetings and reviews, and ensures actions are clearly defined, risk-based, and capable of preventing recurrence.\nReviews CAPA plans for technical adequacy, risk-based decision-making, clear ownership, and realistic timelines.\nLeads and supports structured root cause analysis using appropriate methodologies.\nChallenges inadequate or superficial investigations and drive deeper root cause identification when needed.\nVerifies CAPA effectiveness and ensures appropriate documentation and justification for closure.\nCoordinates CAPA implementation, progress, and closure for Outside Contract Manufacturers (OCMs) and external suppliers. Supports supply chain governance by ensuring external CAPAs are timely, risk-based, and audit-defensible.\nBuilds strong working relationships with Manufacturing, QC, Engineering, QA, Planning, Procurement, and external partners.\nCompiles and maintains CAPA metrics, dashboards, and periodic reports for management review.\nSupports internal audits, third-party audits, and regulatory inspections by providing CAPA documentation and serving as CAPA SME.\nProactively identifies opportunities to improve CAPA workflows, templates, and tools.\nProvides guidance and informal training to internal teams, OCMs, and suppliers on CAPA best practices.\nStays current on regulatory expectations, industry trends, and best practices related to CAPA and quality systems.\nBecomes thoroughly knowledgeable of applicable SOPs and cGMPs and maintains knowledge without reliance on management direction.\nProvides quality review and feedback on new products and processes as required.\nParticipates in process improvement teams to provide quality input and direction.\nEnsures compliance with cGMP, FDA, OSHA, and all other regulatory requirements.\nWHAT YOU NEED\nBachelor’s degree required in a scientific, engineering, or quality-related discipline; or equivalent combination of education and experience. \n5+ years of experience in a cGMP-regulated manufacturing environment with direct involvement in CAPA execution and quality systems. \nExperience supporting or overseeing CAPAs for OCMs and/or suppliers strongly preferred. \nDemonstrated experience in project management or complex cross-functional initiatives preferred. \nAbility to effect change in a positive environment. Must be able to provide constructive arguments and sound justification as it pertains to technical and supplier requirements.\nInitiates and completes reports in a timely manner\nWHAT WE OFFER\nCompetitive compensation\n100% company-paid medical, dental, and vision insurance coverage for employees\nCompany-paid short- and long-term disability insurance\nCompany- paid life insurance\n401k plan with employer matching contributions up to 4%\nGym membership reimbursement\nMonthly allowance of Thorne supplements\nPaid time off, volunteer time off and holiday leave\nTraining, professional development, and career growth opportunities","description_format":"text","description_chars":4817,"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":["401k plan","Growth opportunities","Gym membership","Insurance coverage","Life insurance","Professional development","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Dietary Supplements","Health & Wellness Products"],"lifecycle":[{"event":"open","at":"2026-09-27T17:07:12Z"}],"visa":[],"liveness":{"score":21,"band":"cold","label":"Long shot","p_open":1,"p_active":0.596,"p_room":0.35,"age_days":35,"expected_fill_days":15,"reasons":["conf:2","win:tail"],"computed_at":"2026-11-01T06:10:25Z"},"pay":null,"html_url":"https://alion.io/job/thorne-quality-assurance-capa-specialist","json_url":"https://alion.io/job/thorne-quality-assurance-capa-specialist.json","meta":{"generated_at":"2026-11-01T11:38:35Z","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":18039,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-02T00:00:00Z"}},"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":1769319},"rest":"https://alion.io/mcp/rest/get_company?id=1769319"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fthorne-quality-assurance-capa-specialist"},{"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%2Fthorne-quality-assurance-capa-specialist"},{"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%2Fthorne-quality-assurance-capa-specialist"},{"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/thorne-quality-assurance-capa-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fthorne-quality-assurance-capa-specialist"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1346919}},{"tool":"search_jobs","arguments":{"company":"thorne.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1346919},"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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