{"id":1130585,"url":"https://alion.io/job/streck-quality-assurance-qms-specialist","title":"Quality Assurance (QMS) Specialist","company":{"id":684937,"name":"Streck","domain":"streck.com","url":"https://alion.io/company/streck","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","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":["La Vista, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":60000,"max_usd":108000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":4343},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-09-22T19:31:03Z","employer_posted_date":"2026-09-22","last_verified_at":"2026-11-02T06:16:07Z","board_verified":true,"closed_at":null,"days_open":40,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":40},"description":"The Opportunity\nThis position is responsible for quality activities performed within assigned department(s) and for helping ensure compliance with regulatory requirements and internal procedures. Working under general supervision, the Quality Assurance Specialist provides day-to-day quality support to designated departments and serves as a quality leader within their area of responsibility.\nWhat You'll Do\nSupport investigation and documentation of observations, deviations, and Nonconforming Product/Material Reports, helping identify potential gaps in the quality system.\nLead Root Cause Analysis (RCA) meetings as part of the Corrective and Preventive Action (CAPA) process, and assist with CAPA plan implementation and effectiveness checks.\nSupport implementation of process changes arising from Change Control through training and direct observation.\nDeliver quality training to new hires and provide ongoing training as needed.\nPerform biannual audits of equipment in assigned areas.\nMaintain visibility into operations through routine direct observation, partnering closely with Operations staff on error prevention.\nAssist with writing and revising Standard Operating Procedures (SOPs).\nCollect and analyze quality data and metrics, and help communicate trends to management.\nParticipate in continuous improvement initiatives and project validation teams.\nSupport review and retention of Device History Records (DHRs).\nDepending on area of assignment, perform batch record and lot file reviews, in-process and final quality checks, packaging line clearance checks, and related inspections across Manufacturing, Fill/Label, Distribution, QC, QC Lab, and/or BCT Facility functions.\nWhat We're Looking For\nEducation & Experience\nAssociate degree required; Bachelor's degree in a STEM or related discipline preferred.\n1-4 years of related work experience in an FDA-regulated manufacturing environment; relevant quality experience (2-3 years), preferably in an FDA or USDA industry, may substitute for technical education.\nSkills & Attributes\nStrong PC skills, including proficiency with Microsoft Word and Excel.\nHigh attention to detail.\nQuality auditing certification preferred.\nAccountability, customer focus, professionalism, quality orientation, and a strong team focus.\nWork Environment\nThis role is based in a climate-controlled biological/chemical laboratory, with occasional short-duration exposure to cold temperatures in walk-in coolers. The role requires the ability to wear required cleanroom and personal protective equipment for up to two and a half hours consecutively, and involves standing, walking, lifting up to 55 lbs occasionally, and other physical activity described in the full job description. Travel is estimated at up to 5%.\nStreck Offerings\nA challenging, safe and rewarding work environment \nNo night or weekend shifts \nExcellent work life balance \nMarket competitive pay \nComprehensive and inclusive benefits \nGreat team environment \nOn and off campus career development opportunities","description_format":"text","description_chars":3022,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"associate","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Diagnostic Tests & IVD","Molecular Diagnostics"],"lifecycle":[{"event":"open","at":"2026-09-23T02:03:14Z"}],"visa":[],"liveness":{"score":34,"band":"fade","label":"Fading","p_open":1,"p_active":0.771,"p_room":0.44,"age_days":40,"expected_fill_days":40,"reasons":["conf:4","win:tail","crowd:junior"],"computed_at":"2026-11-02T06:13:15Z"},"pay":null,"html_url":"https://alion.io/job/streck-quality-assurance-qms-specialist","json_url":"https://alion.io/job/streck-quality-assurance-qms-specialist.json","meta":{"generated_at":"2026-11-02T09:39:59Z","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":13581,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-03T00:00:00Z"}},"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":684937},"rest":"https://alion.io/mcp/rest/get_company?id=684937"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fstreck-quality-assurance-qms-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%2Fstreck-quality-assurance-qms-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%2Fstreck-quality-assurance-qms-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/streck-quality-assurance-qms-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fstreck-quality-assurance-qms-specialist"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1130585}},{"tool":"search_jobs","arguments":{"company":"streck.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1130585},"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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