{"id":2691323,"url":"https://alion.io/job/alcami-associate-manufacturing-specialist","title":"Associate Manufacturing Specialist","company":{"id":2280572,"name":"Alcami","domain":"alcami.com","url":"https://alion.io/company/alcami","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"iCIMS","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":["Morrisville, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":55000,"max_usd":99000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":3735},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":true}],"status":"live","first_seen_at":"2026-10-16T09:00:26Z","employer_posted_date":"2026-10-16","last_verified_at":"2026-10-18T01:30:46Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.\nAre you interested in joining our team?\nJob Summary\nThe Associate Manufacturing Specialist is accountable for driving results in a fast-paced environment by being responsible to manufacture various products following a specific protocol while in full compliance with all cGMP procedures and guidelines.\nThe Associate Manufacturing Specialist is responsible for handling, reviewing, and ensuring the accuracy, completeness, and compliance of all manufacturing documentation associated with formulation and aseptic filling operations. This role ensures that Good Documentation Practices (GDP) are consistently upheld and that batch records are processed efficiently to support on-time product release.\nOn-Site Expectations\n100% on-site position.\n1st Shift: Monday - Friday, 8:00am - 4:30pm.\nResponsibilities\nBatch Record Handling & Review:\nReceive, organize, and manage all formulation and aseptic filling batch records and associated documentation.\nPerm detailed review of batch records for accuracy, completeness, and compliance with cGMP, GDP, and internal SOPs.\nIdentify, document, and facilitate resolution of discrepancies, errors, and missing information / reports.\nEnsure timely completion of record review to meet established batch release timelines.\nProvide feedback and training to manufacturing technicians to support right first-time manufacturing initiatives.\nPerform logbook reviews and support corrective action as necessary.\nDocumentation Quality & Compliance\nServe as subject matter resource for GDP requirements across manufacturing teams.\nEnsure documentation is legible, traceable, contemporaneous, accurate, and compliant with regulatory expectations.\nMaintain control of revision processes and ensure the correct versions of forms and records are in circulation.\nSupport internal and external audit readiness by ensuring documentation accuracy and availability.\nTraining & Continuous Improvement\nTrain manufacturing personnel on proper documentation practices, batch record / logbook review, and general batch record handling expectations.\nProvide feedback and coaching to operators and supervisors, to strengthen compliance culture.\nParticipate in root cause analysis for documentation-related deviations or recurring errors.\nRecommend and support implementation of documentation process improvements.\nCross-Functional Support\nWork closely with Manufacturing, Quality Assurance, and Supply Chain to align on documentation needs and timelines.\nSupport investigations by providing relevant documentation insights and historical reference.\nAssist in preparing documentation summaries or metrics for management review.\nMay require periodic presence on the production floor.\nOther duties as assigned.\nQualifications\nBachelor’s degree in Life Sciences, Engineering, or a related field preferred; equivalent experience considered.\nMust have 1 - 3+ years in related GDP environment. Pharmaceutical, biotech, or aseptic manufacturing operations work experience preferred.\nKnowledge, Skills, and Abilities\nExperience with batch record review, GDP, or cGMP environments highly desirable.\nStrong attention to detail and ability to identify errors and inconsistencies.\nStrong verbal and written communication and documentation skills required.\nStrong detail orientation and organizational skills required.\nAbility to collaborate cross-functionally and provide constructive feedback.\nAbility to manage multiple priorities in a fast-paced environment.\nAbility to work extended hours during peak production or release periods.\nAble to work with Microsoft Office (Word, Excel, PowerPoint) required.\nTravel Expectations\nUp to 5% travel required.\nPhysical Demands and Work Environment\nThe 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 accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to stand. The employee is occasionally required to walk; sit and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.\nWhile performing the duties of this job, the employee is frequently exposed to moving mechanical parts and the risk of electrical shock, burn hazards and microbial contamination. The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.","description_format":"text","description_chars":5506,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology"],"lifecycle":[{"event":"open","at":"2026-10-16T09:00:26Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":18,"reasons":["conf:3","win:early","comp:junior"],"computed_at":"2026-10-17T05:46:00Z"},"pay":null,"html_url":"https://alion.io/job/alcami-associate-manufacturing-specialist","json_url":"https://alion.io/job/alcami-associate-manufacturing-specialist.json","meta":{"generated_at":"2026-10-18T04:35:41Z","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":6862,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-19T00:00:00Z"}},"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":2280572},"rest":"https://alion.io/mcp/rest/get_company?id=2280572"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Falcami-associate-manufacturing-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%2Falcami-associate-manufacturing-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%2Falcami-associate-manufacturing-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/alcami-associate-manufacturing-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Falcami-associate-manufacturing-specialist"}]}