{"id":2348041,"url":"https://alion.io/job/amgen-manufacturing-senior-associate","title":"Manufacturing Senior Associate","company":{"id":4775,"name":"Amgen","domain":"amgen.com","url":"https://alion.io/company/amgen","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":79,"open_postings":419,"ghost_share":0.002,"stale_share":0.838,"repost_share":0.007,"time_to_fill_p50_days":27,"computed_at":"2026-10-13T05:45:00Z"}},"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":["Hyderabad, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":15500,"max_usd":39000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":20},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-12T13:07:56Z","employer_posted_date":"2026-10-12","last_verified_at":"2026-10-13T01:14:33Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Career Category\nManufacturingJob Description\nJob Description\nHOW MIGHT YOU DEFY IMAGINATION?\nAt Amgen, our shared mission is to serve patients. Every team member contributes to our ability to consistently deliver high-quality medicines through excellence in operations, compliance, and continuous improvement.\nThe Manufacturing Senior Associate is responsible for the authoring, revision, coordination, and lifecycle management of Manufacturing controlled documents. This role partners closely with Manufacturing, Quality, Process Development, Engineering, Validation, and other cross-functional stakeholders to ensure procedures and documentation remain accurate, compliant, effective, and inspection-ready.\nThe individual serves as a key document management and process improvement resource, facilitating complex document revisions and authoring, coordinating stakeholder reviews, driving on-time completion of commitments, and supporting Manufacturing performance through effective documentation practices specifically in DS, DP, or FDP. In some instances may act as the overall business process owner for DS, DP, or FDP. Hours for this role may vary based on global time zones, which could include hybrid hours, on call requirements, and flexible working hours.\nKey Responsibilities\nDocument Authoring & Lifecycle Management\nAuthor, revise, and maintain controlled GMP documents in collaboration with the document owner. Documents include:Standard Operating Procedures (SOPs)\nForms\nProtocols\nReports\nGlobal Document Elements (GDEs)\nWork Instructions\nTraining Documents\nOther controlled GMP documentation\n\nEnsure documents comply with Good Documentation Practices (GDP), cGMP requirements, site procedures, and global standards.\nPerform periodic reviews of controlled documents and drive completion of required updates.\nReview existing procedures for accuracy, consistency, and process alignment.\nIdentify opportunities to improve document effectiveness, usability, and compliance.\nCross-Functional Coordination\nFacilitate document review meetings and revision workshops with subject matter experts and stakeholders, across various sites in the network\nCoordinate comment resolution across multiple functional groups.\nConsolidate feedback and incorporate approved revisions into final documents.\nDrive stakeholder alignment in partnership with the sponsoring area owneron document content, process changes, and implementation plans.\nPartner with Quality, Validation, Engineering, Manufacturing, and Technical Services to ensure documentation supports operational needs.\nProject & Revision Management\nManage multiple complex document revisions simultaneously.\nDevelop and maintain document revision schedules and status trackers.\nMonitor progress against established timelines and commitments.\nEscalate risks, delays, and resource constraints as appropriate.\nLead efforts to complete high-priority and inspection-related documentation updates.\nMetrics & Operational Support\nGenerate and analyze documentation performance metrics and reports.\nTrack key performance indicators related to document health, overdue reviews, revision cycle times, and compliance commitments.\nPrepare performance metrics for communication to leadership and stakeholders\nDrive actions to improve documentation effectiveness, compliance, and right-first-time performance.\nSupport audit and inspection readiness activities through documentation monitoring and reporting, if required.\nContinuous Improvement\nIdentify opportunities to streamline documentation processes and workflows.\nParticipate in process improvement initiatives and digital transformation efforts.\nRecommend and implement solutions that improve document quality, compliance, and efficiency.\nContribute to standardization efforts across manufacturing organizations and sites.\nBasic Qualifications\nGraduation with 5 to 9 years of experience\nPreferred Qualifications\nExperience in a GMP-regulated manufacturing environment.\nExperience authoring and revising SOPs, protocols, reports, forms, and controlled documentation.\nStrong technical writing and document management skills.\nExperience facilitating cross-functional meetings and stakeholder reviews.\nKnowledge of Good Documentation Practices (GDP) and cGMP requirements.\nExperience using electronic document management systems (e.g., Veeva, CDOCS, EDMS, TrackWise, etc.).\nAbility to manage multiple priorities and deadlines simultaneously.\nStrong project management and organizational skills.\nExperience generating and analyzing operational metrics and performance reports.\nDemonstrated ability to influence stakeholders without direct authority.\nStrong communication, collaboration, and facilitation skills.\nExperience leading continuous improvement initiatives.\nCompetencies\nConsistent with the Manufacturing Senior Associate (GCF 4) competency model, success in this role requires demonstrated capability in:\nDemonstrating Technical Expertise\nOperating with Precision\nWorking in Partnership\nTroubleshooting and Solving Problems\nInspiring High Performance\nStriving for Your Best\nKey Measures of Success\nOn-time completion of document revisions\nReduction in overdue document reviews\nRight-first-time document approval rate\nCycle time for document revision and approval\nCompliance with GMP and documentation standards\nInspection readiness and audit support effectiveness\nStakeholder satisfaction\nContinuous improvement implementation and value delivery\n.","description_format":"text","description_chars":5448,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Flexible schedule"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Biologics & Biosimilars","Immunology & Inflammation Therapeutics","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-12T13:07:56Z"}],"visa":[],"liveness":{"score":60,"band":"ok","label":"Likely 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