{"id":1330344,"url":"https://alion.io/job/august-bioservices-sterile-injectable-cdmo-quality-engineer","title":"Quality Engineer","company":{"id":3783650,"name":"August Bioservices","domain":"augustbio.com","url":"https://alion.io/company/augustbio","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"C","score":63,"open_postings":24,"ghost_share":0.625,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":53,"computed_at":"2026-10-19T05:45:15Z"}},"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":["Nashville, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":85000,"max_usd":160000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":5578},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2024-09-23T21:51:58Z","employer_posted_date":"2024-09-23","last_verified_at":"2026-10-19T07:11:48Z","board_verified":true,"closed_at":null,"days_open":755,"trust":{"level":"ghost","repost_count":0,"flags":["stale","company_stale"],"days_open":755},"description":"The Quality Engineer is responsible for supporting incoming new client projects from the Quality perspective at August Bioservices. Successful candidates will be a team player and have exceptional technical and communication skills, a strong background in Quality, and a high ability to collaborate with various levels of the organization.\nResponsibilities\nThe Quality Assurance Engineer represents the Quality function in internal and external meetings related to new client projects, determining deliverables and timelines, and communicating upcoming activities with all of the Quality Organization (Quality Assurance, Quality Control and Validation). \nSupport technology transfer of product and processes from clients into August Bioservices manufacturing and laboratories from the Quality perspective. Project may span R&D, Formulation Development, Clinical, and Commercial Manufacturing.\nWorks cross functionally with various internal departments to effectively transfer and maintain processes in the facility. \nHelp proactively identify CMC critical path items, risks, and impediments to successful transfer, and drive the identification and development of solutions to help mitigate these risks. \nProvide support on projects to streamline new product introduction, provide feedback in Change Review Board for change controls to introduce new products. \nDevelop and implement phase appropriate strategies for efficient transfers and identification of Quality deliverables.\nWorks with Product Quality Assurance and Manufacturing to support generation of appropriate batch documentation.\nCommunicates project status, upcoming deliverables and timeliness to the Quality Organization.\nThis position will work in a cross-functional group with Manufacturing, Engineering, Supply Chain, and Commercial Operations to drive technical transfer of client products into August Bioservices for manufacture and laboratory testing. \nThis position will be client facing and the candidate should possess the ability to work collaboratively with clients and internal cross-functional stakeholders to move projects forward.\nProvides support during internal audits and regulatory inspections. \nAdhere to company policies and applicable regulatory agencies requirements (ICH, FDA etc.) to ensure compliance.\nCommunicate clearly with cross-functional teams.\nRequirements\nBachelor’s or Master’s Degree and 5+ years of experience in Quality Assurance within a biotechnology, biologics, or pharmaceutical manufacturing facility. \nMust have proven track record with CMC and technology transfer.\nGMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing and Part 11 compliance knowledge preferred.\nWork occurs in a fast-paced environment. Individual must be able to efficiently prioritize own work and quickly communicate project information to the team.\nPhysical Requirements\n The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\nProlonged periods sitting at a desk and working on a computer.\nMust be able to lift up to 15 pounds at times.","description_format":"text","description_chars":3468,"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":false,"industries":["CRO & CDMO Services","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-09-27T09:26:49Z"}],"visa":[],"liveness":{"score":6,"band":"cold","label":"Long shot","p_open":1,"p_active":0.222,"p_room":0.28,"age_days":755,"expected_fill_days":53,"reasons":["conf:2","stale_co","ghost","win:tail","crowd:"],"computed_at":"2026-10-19T05:45:15Z"},"pay":null,"html_url":"https://alion.io/job/august-bioservices-sterile-injectable-cdmo-quality-engineer","json_url":"https://alion.io/job/august-bioservices-sterile-injectable-cdmo-quality-engineer.json","meta":{"generated_at":"2026-10-19T08:16:37Z","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":5404,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-20T00:00:00Z"}},"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":3783650},"rest":"https://alion.io/mcp/rest/get_company?id=3783650"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Faugust-bioservices-sterile-injectable-cdmo-quality-engineer"},{"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%2Faugust-bioservices-sterile-injectable-cdmo-quality-engineer"},{"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%2Faugust-bioservices-sterile-injectable-cdmo-quality-engineer"},{"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/august-bioservices-sterile-injectable-cdmo-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Faugust-bioservices-sterile-injectable-cdmo-quality-engineer"}]}