{"id":2534826,"url":"https://alion.io/job/twist-bioscience-qa-associate-ii","title":"QA Associate II","company":{"id":1814479,"name":"Twist Bioscience","domain":"twistbioscience.com","url":"https://alion.io/company/twistbioscience","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"B","score":78,"open_postings":11,"ghost_share":0,"stale_share":0.818,"repost_share":0.091,"time_to_fill_p50_days":31,"computed_at":"2026-10-14T06:34:16Z"}},"role":"Science & Research","role_family":"Science & Research","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Portland, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":75000,"max_usd":155000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":592},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Confluence","optional":false},{"name":"GCP","optional":false}],"status":"live","first_seen_at":"2026-10-14T12:28:08Z","employer_posted_date":"2026-10-14","last_verified_at":"2026-10-15T04:24:54Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"The QA Associate II is responsible for ensuring the accurate, compliant, and timely release of Twist’s synthetic biology products, with a primary focus on batch record review, raw material and lot release, and quality event support. Working in an ISO 13485 manufacturing environment, this role partners closely with production, equipment, and subject matter experts to investigate quality events, support root cause analysis, and keep documentation and processes inspection-ready. A strong working knowledge of cGMP and IVD regulatory requirements, along with high attention to detail and clear communication, is critical to success in this role. This is a great opportunity for a quality professional who enjoys hands-on, on-site work and wants to grow their impact by mentoring peers and supporting internal and external audits.\nKnowledge & Application\nEnsures the accurate and safe release of various synthetic biology products in accordance with company and/or client procedures and requirements.\nEnsures and promotes compliance with applicable ISO, cGMP, IVD Regulations, and company and client SOPs.\nAuthors and reviews relevant SOPs, batch records, labels and other documents.\nManufacturing Batch Record review, control, release, including label verification.\nMaterials management (including Raw Material Release), nonconformance disposition and release activity as applicable.\nCollaborates with SMEs to investigate Quality event tickets and assign, approve, or follow up on approval and disposition of these events.\nReview and releases IQOQPQs through collaboration with the Equipment team.\nSupport the tracking and trending relevant quality metrics as assigned.\nSupport investigations, root cause analysis, and documentation of findings on Quality Events.\nConduct lab walkthroughs on a periodic basis and report and follow up on findings.\nEffectively influences (by serving as a peer mentor) and trains employees on basic releases and processes.\nSupports internal and external audits via gathering and preparation of audit material.\nSupport additional responsibilities as assigned.\nAbility to be on-site to inspect products/materials and release lots.\nFollow regulatory and ISO 13485 requirements.\nComplexity & Problem Solving\nExecutes tasks/assignments that have clear and established processes and procedures. At times, tasks/assignments require occasional adaptation beyond established processes and procedures.\nCollaboration & Interaction\nFollows established procedures on routine work, receives instructions only on new assignments.\nTypical Degree & Years of Experience\nBachelors degree (or equivalent) in a scientific /engineering related field\n2-3 years of experience in the medical device/pharmaceutical/biotech industry.\nMinimum 2 years of Quality Assurance or Regulatory Compliance (e.g. GCP, cGMP, GLP) experience.\nExperience working and/or supporting production/laboratories a plus.\nFamiliarity with regulatory requirements for IVD Products, ISO 13485, 21CFR820, MDD, applicable experience in medical device, or biotech manufacturing and a thorough knowledge and understanding of cGMP.\nFamiliarity with Confluence and JIRA applications desired.\nStrong written and verbal communication skills.\nAnalytical and problem-solving skills.\nProven ability to work cross-functionally to achieve business outcomes.","description_format":"text","description_chars":3324,"description_truncated":false,"requirements":{"experience_years_min":2,"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":false,"industries":["Genomics & Genetic Testing","Synthetic Biology"],"lifecycle":[{"event":"open","at":"2026-10-14T13:53:36Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 15 · green card filings: 5","filings_12m":15,"filings_prev_12m":20,"green_card_filings_12m":5,"median_offered_wage_usd":133750,"route":null,"cap_exempt":false,"checked_at":"2026-10-03T21:08:04+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":31,"reasons":["conf:0","win:early"],"computed_at":"2026-10-15T04:34:00Z"},"pay":null,"html_url":"https://alion.io/job/twist-bioscience-qa-associate-ii","json_url":"https://alion.io/job/twist-bioscience-qa-associate-ii.json","meta":{"generated_at":"2026-10-15T04:34:00Z","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":6635,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-16T00:00:00Z"}},"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":1814479},"rest":"https://alion.io/mcp/rest/get_company?id=1814479"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Ftwist-bioscience-qa-associate-ii"},{"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%2Ftwist-bioscience-qa-associate-ii"},{"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%2Ftwist-bioscience-qa-associate-ii"},{"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/twist-bioscience-qa-associate-ii\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ftwist-bioscience-qa-associate-ii"}]}