{"id":2797157,"url":"https://alion.io/job/bora-pharmaceuticals-specialist-i-quality-operations","title":"Specialist I, Quality Operations","company":{"id":2156158,"name":"Bora Pharmaceuticals","domain":"boracdmo.com","url":"https://alion.io/company/boracdmo","size_band":"1-10","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":88,"open_postings":6,"ghost_share":0,"stale_share":0.5,"repost_share":0,"time_to_fill_p50_days":35,"computed_at":"2026-10-30T05:48:23Z"}},"role":"Science & Research","role_family":"Science & Research","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":["Baltimore, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":48000,"max_usd":102000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":849},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-10-17T23:59:38Z","employer_posted_date":"2026-10-17","last_verified_at":"2026-10-30T10:34:18Z","board_verified":true,"closed_at":null,"days_open":12,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":12},"description":"About Bora\nBora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products.\nFrom our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide.\nAt Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain.\nJob Summary\nThis position provides technical quality support for manufacturing processes, equipment, facilities, and product lifecycle activities within the Quality Assurance Department. Primary responsibilities include leading investigations and root cause analysis, assessing process and product risk, reviewing validation and qualification documentation, analyzing performance trends, supporting change controls and technology transfers, and developing sustainable corrective actions and process improvements. The role helps ensure compliant, capable, and reliable operations. This position is on-site, full-time.\nEssential Functions\nReasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.\nProvides technical quality oversight and support for assigned manufacturing processes, products, equipment, facilities, and client programs.\nPartners with cross-departmentally to resolve complex quality and compliance issues.\nLeads or supports assigned investigations of deviations, complaints, PAs, OOS, OOT, and other non-conformances using structured root cause analysis tools.\nHelps develop, evaluate, and monitor corrective and preventive actions to ensure timely completion and sustained effectiveness.\nPerforms quality risk assessments, impact assessments, and gap analyses for processes, products, equipment, facilities, and proposed changes.\nReviews and approves protocols, reports, specifications, procedures, and technical documentation associated with validation, qualification, stability, and continued process verification activities.\nEvaluates process capability, product performance, and quality-system data; identifies adverse trends and recommends appropriate actions.\nApplies statistical and analytical tools to support investigations, trend analysis, risk-based decisions, and process improvement.\nProvides quality expertise and insight for change controls, process changes, equipment or facility modifications, technology transfers, and new product introductions.\nIdentifies opportunities to improve process robustness, reliability, compliance, and operational efficiency and supports implementation of approved improvements.\nSupports annual product reviews, regulatory submissions, client responses, inspections, and audits by providing technical assessments and quality documentation.\nServes as a technical quality resource for cross-functional teams and communicates risks, recommendations, and decisions clearly to stakeholders.\nSupports the development and maintenance of quality metrics, dashboards, and management-review inputs.\nMaintains current knowledge of cGMP requirements, applicable regulations, industry standards, and site procedures.\nThis position may be trained using Virtual Reality and/or AI.\nThe above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.\n\nMinimum Education, Skills and Experience\nBachelor’s degree in engineering, pharmaceutical science, life sciences, or technical discipline.\n5-7 years of experience supporting pharmaceutical, biologics, or other regulated manufacturing operations; CDMO experience or sterile finished required.\nDemonstrated experience leading or supporting deviations, investigations, OOS/OOT events, complaints, and other non-conformances using structured root cause analysis methods.\nExperience developing, implementing, and assessing the effectiveness of corrective and preventive actions.\nWorking knowledge of process validation, equipment and facility qualification, change control, technology transfer, and continued process verification.\nDemonstrated ability to analyze process and product data using statistical tools, identify trends, and translate findings into risk-based recommendations.\nAbility to evaluate process capability, product performance, and quality-system effectiveness and recommend sustainable improvements.\nStrong technical writing skills with experience reviewing and authoring investigations, protocols, reports, risk assessments, procedures, specifications, and regulatory or client-facing documentation.\nAdvanced knowledge of cGMP requirements, applicable FDA and EU regulations, ISO standards, and other relevant industry guidance.\nCompensation and Benefits\nWe offer a comprehensive benefits package designed to support our employees’ wellbeing, including:\nCompetitive salary and performance-based incentives\n\nComprehensive health coverage including medical, dental, and vision insurance\n\nRetirement savings plans with employer matching contributions\n\nPaid time off\n\nProfessional development opportunities\n\nEmployee wellness programs and resources\n\nEmployee Assistance Program and Mental Health Resources\n\nCore Values\nAt Bora, our values guide everything we do - from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.\nBora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.","description_format":"text","description_chars":6768,"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":["Professional development","Retirement plans","Vision insurance","Wellness"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["CRO & CDMO Services","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-17T23:59:38Z"}],"visa":[],"liveness":{"score":81,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.813,"p_room":1,"age_days":12,"expected_fill_days":35,"reasons":["conf:7","win:early","comp:junior"],"computed_at":"2026-10-30T05:48:23Z"},"pay":null,"html_url":"https://alion.io/job/bora-pharmaceuticals-specialist-i-quality-operations","json_url":"https://alion.io/job/bora-pharmaceuticals-specialist-i-quality-operations.json","meta":{"generated_at":"2026-10-30T14:01:34Z","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":1326,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-31T00:00:00Z"}},"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":2156158},"rest":"https://alion.io/mcp/rest/get_company?id=2156158"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbora-pharmaceuticals-specialist-i-quality-operations"},{"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%2Fbora-pharmaceuticals-specialist-i-quality-operations"},{"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%2Fbora-pharmaceuticals-specialist-i-quality-operations"},{"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/bora-pharmaceuticals-specialist-i-quality-operations\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbora-pharmaceuticals-specialist-i-quality-operations"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2797157}},{"tool":"search_jobs","arguments":{"company":"boracdmo.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2797157},"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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