{"id":1556917,"url":"https://alion.io/job/american-regent-qa-operations-associate-i","title":"QA Operations Associate I","company":{"id":2011712,"name":"American Regent","domain":"americanregent.com","url":"https://alion.io/company/americanregent","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":80,"open_postings":6,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":12,"computed_at":"2026-10-13T05:45:00Z"}},"role":"Operations","role_family":"Operations","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["New Albany, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":45000,"max_usd":94000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":2011},"experience_years_min":1,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-28T00:00:00Z","employer_posted_date":"2026-09-28","last_verified_at":"2026-10-13T17:51:23Z","board_verified":true,"closed_at":null,"days_open":16,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":16},"description":"Nature and Scope\nThis position is responsible for ensuring the overall Quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. Ensures all processes and products meet specifications and that products are produced in accordance with GMP requirements.\nEssential Duties and Responsibilities\nNothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.\nAchieve and maintain packaging line and inspection room clearance qualification\nConduct accurate verifications and checks as well as accurate process inspections\nConduct accurate packaging AQL inspections\nIdentify out of specification product, ensuring segregation and escalation, as required\nEnsure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirements\nEnsure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health and safety requirements.\nConduct component and raw material release\nConduct chart monitoring, ensuring escalation, as required\nSupport product shipping activities and perform quality related oversight and verifications\nGenerate logbooks and sheets/labels\nReview Bills of Materials\nBasic knowledge of cGMPs and supporting regulatory documents\nAchieve and maintain clean side gown and sterile side gown qualifications\nAchieve and maintain Class A qualification\nPerform room, area and equipment clearances.\nParticipate in Media Fill and maintain qualification\nAble to perform tasks with minimal error rate.\nPerform any other tasks/duties as assigned by management.\nEducation Requirements and Qualifications\nTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.\nHigh School Diploma or GED equivalent required. Associates or Bachelor’s Degree preferred.\nMinimum 1 year work experience in a FDA regulated environment or similarly regulated area is preferred.\nMust be able to do work independently.\nIntermediate skills in Microsoft Word and Excel are required.\nExcellent organizational, interpersonal and communication skills (written and oral) required.\nAbility to take feedback constructively and function in a team oriented work environment.\nAbility to work overtime as needed.\nPhysical Environment and Requirements\nPhysically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. \nSpecific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.\nEmployees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.\nEmployee must be able to occasionally lift and/or move up to 25 pounds.\nAmerican Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.\nApplicants have rights under Federal Employment Laws.\nFMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf\n\nKnow Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)\n\nEmployee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf\n\nAlert: We’re aware of individuals impersonating our staff to target job seekers. Please note:\n·All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.\n·Our recruiting process includes multiple in person and/or video interviews and assessments.\n·If you are unsure about the legitimacy of a message, contact John Rossini at  before responding.\n·We never request payment, bank information, or personal financial details during our offer process.\nYour security is important to us, and we encourage you to stay vigilant when job searching.\nAmerican Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email .","description_format":"text","description_chars":4629,"description_truncated":false,"requirements":{"experience_years_min":1,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"high_school","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Dietary Supplements"],"lifecycle":[{"event":"open","at":"2026-10-01T02:23:40Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 3 · green card filings: 1","filings_12m":3,"filings_prev_12m":3,"green_card_filings_12m":1,"median_offered_wage_usd":112500,"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":30,"band":"fade","label":"Fading","p_open":1,"p_active":0.544,"p_room":0.55,"age_days":15,"expected_fill_days":12,"reasons":["conf:3","velocity","win:tail","comp:junior"],"computed_at":"2026-10-13T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/american-regent-qa-operations-associate-i","json_url":"https://alion.io/job/american-regent-qa-operations-associate-i.json","meta":{"generated_at":"2026-10-14T00:34:58Z","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":817,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-15T00:00:00Z"}},"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":2011712},"rest":"https://alion.io/mcp/rest/get_company?id=2011712"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Famerican-regent-qa-operations-associate-i"},{"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%2Famerican-regent-qa-operations-associate-i"},{"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%2Famerican-regent-qa-operations-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/american-regent-qa-operations-associate-i\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Famerican-regent-qa-operations-associate-i"}]}