{"id":4167020,"url":"https://alion.io/job/baxter-quality-sme-production-process-controls","title":"Quality SME, Production & Process Controls","company":{"id":5835,"name":"Baxter","domain":"baxter.com","url":"https://alion.io/company/baxter","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":93,"open_postings":37,"ghost_share":0,"stale_share":0.432,"repost_share":0.054,"time_to_fill_p50_days":17,"computed_at":"2026-11-12T10:38:37Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"staff","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Marion, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":112000,"max":140000,"currency":"USD","period":"year","gross":null,"usd_annual":140000},"salary_estimate":null,"experience_years_min":15,"visa_sponsorship":true,"relocation_package":false,"has_equity":true,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-11-12T13:42:04Z","employer_posted_date":"2026-11-12","last_verified_at":"2026-11-12T13:42:04Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"This is where your work makes a difference.\nAt Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.\nOur Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.\nHere, you will find more than just a job-you will find purpose and pride.\nYour Role at Baxter\nThis is where your creativity addresses challenges\nYou are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Quality Manager II, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.\nYour Team at Baxter\nWithin Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role, it is sure to touch a portion of our global operation.\nThe mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.\nThe Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.\nWe build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.\nWhat you'll be doing\nServe as the division Quality Compliance technical SME for production and process controls, including statistical sampling, in-process control checks, manufacturing process flows, and batch record compliance across ITP sites.\nProvide strategic and technical Quality Compliance guidance on production and process controls for sterile preparations, with a focus on manufacturing process controls and their compliance adequacy.\nProvide specialist guidance and independent compliance assessment of visual inspection programs, including inspection methods, qualification, defect classification, acceptance criteria, sampling strategies, investigations, and inspection performance trends.\nProvide specialist Quality Compliance guidance on particulate matter prevention and control, including assessment of particulate sources, monitoring and trending, investigation adequacy, and the effectiveness of site-owned corrective and preventive actions.\nProvide specialist Quality Compliance guidance on container closure integrity testing (CCIT), including review of testing strategies, method suitability and validation, lifecycle controls, investigations, and remediation adequacy, in partnership with relevant site functions and the Sterility Assurance SME.\nSupport all sites in sustaining an Always Inspection Ready state through risk-based assessments, readiness reviews, mock inspections, coaching, and timely closure of identified gaps.\nProvide direct technical support during health authority inspections, including real-time assessment of production and process control questions, evidence review, response development, and follow-up commitments.\nLead or support technical compliance assessments and remediation oversight associated with inspection observations, regulatory commitments, significant quality signals, and systemic production or process control weaknesses; challenge whether site-owned actions are risk-based, sustainable, and verified for effectiveness.\nIndependently assess end-to-end manufacturing processes for compliance with approved procedures, validated process requirements, product specifications, and regulatory expectations, and recommend actions to address identified gaps.\nPerform and lead risk-based assessments of manufacturing operations, process control systems, production practices, manufacturing documentation, and operational execution.\nReview and challenge manufacturing-related deviations, investigations, process excursions, batch failures, human error events, repeat deviations, and product impact assessments.\nEvaluate process control strategies, in-process monitoring programs, alarm management practices, and manufacturing controls to ensure consistent product quality and process robustness.\nProvide technical compliance guidance on site-owned remediation plans addressing manufacturing compliance gaps, process weaknesses, recurring deviations, and inspection observations; review their adequacy and effectiveness.\nAssess procedural adherence, manufacturing discipline, shift execution, line clearance practices, batch documentation practices, and operational GMP behaviors; identify compliance gaps and recommend improvements to accountable site functions.\nProvide independent compliance review and technical guidance on proposed manufacturing process changes and standardization, using quality risk management and process performance monitoring to assess whether controls remain adequate.\nPartner with site leadership to improve investigation quality, root cause analysis, CAPA effectiveness, and operational ownership of compliance issues.\nConduct site assessments, manufacturing system reviews, gap analyses, and mock inspections to identify vulnerabilities and opportunities for improvement.\nMonitor manufacturing compliance performance, recurring trends, process capability indicators, and operational risk signals, escalating significant concerns as necessary.\nCoach and mentor manufacturing, quality, and technical personnel on production controls, process discipline, GMP expectations, and regulatory requirements.\nInterpret current regulatory expectations and industry best practices related to pharmaceutical manufacturing operations and process control systems, and advise site functions on compliant implementation.\nWhat you'll bring\nBachelor’s degree in engineering, Pharmacy, Chemistry, Life Sciences, Manufacturing, Industrial Engineering, or related technical discipline required.\nAdvanced degree preferred.\nMinimum 15 years of experience in pharmaceutical quality, compliance, manufacturing, process engineering, technical services, or related technical functions, including substantial experience assessing production and process controls from a quality and compliance perspective.\nExperience in sterile manufacturing, injectable products, IV solutions, aseptic processing, biologics, or combination products.\nDeep technical knowledge of pharmaceutical production and process controls, batch execution, and production quality systems, with the ability to apply this expertise in independent Quality Compliance assessment and oversight.\nDemonstrated specialist expertise in production and process controls for sterile preparations, visual inspection, particulate matter prevention and control, and container closure integrity testing (CCIT), with the ability to provide strategic and practical technical guidance, independently assess compliance gaps, and challenge the adequacy of site-owned controls and remediation.\nStrong understanding of current global regulatory expectations applicable to pharmaceutical manufacturing, including FDA, EMA, MHRA, Health Canada, ANVISA, INVIMA, TGA, and other health authorities.\nDemonstrated experience supporting health authority inspections, regulatory responses, and remediation activities involving manufacturing and production control systems.\nStrong knowledge of:Pharmaceutical manufacturing processes\nProcess control strategies\nBatch manufacturing practices\nManufacturing documentation systems\nElectronic batch records and manufacturing systems\nDeviations and investigations\nCAPA systems\nProcess validation lifecycle concepts\nChange control systems\nQuality Risk Management\nData integrity requirements\nContinued Process Verification (CPV)\n\nStrong understanding of manufacturing execution systems, operational controls, and product lifecycle management within GMP-regulated environments.\nAbility to evaluate complex manufacturing issues, identify systemic vulnerabilities, and provide practical, risk-based recommendations.\nStrong root cause analysis, investigation, CAPA development, and effectiveness verification skills.\nEffective communication, facilitation, coaching, and influencing skills with the ability to work directly with plant leadership and cross-functional manufacturing teams.\nAbility to maintain a strong on-site presence and travel regularly among supported. manufacturing locations.\nOther Duties as Assigned\nPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Overtime is worked as required.\nWe understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $112,000 - $140,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.\nApplicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.\nUS Benefits at Baxter (except for Puerto Rico)\nThis is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Empl...","description_format":"text","description_chars":13418,"description_truncated":true,"requirements":{"experience_years_min":15,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Insurance coverage","Parental leave","Retirement plans"],"hiring_locations":[],"hiring_excludes":[{"name":"Puerto Rico","iso":"PR"}],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Patient Monitoring","Hospital Equipment & Furniture","Infusion & Drug Delivery Devices"],"lifecycle":[{"event":"open","at":"2026-11-12T13:42:04Z"}],"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":17,"reasons":["conf:1","win:early","comp:brand"],"computed_at":"2026-11-12T15:28:18Z"},"pay":{"stated_usd_annual":140000,"is_top_pay":false},"html_url":"https://alion.io/job/baxter-quality-sme-production-process-controls","json_url":"https://alion.io/job/baxter-quality-sme-production-process-controls.json","meta":{"generated_at":"2026-11-12T15:28:18Z","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":32295,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-13T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":5835},"rest":"https://alion.io/mcp/rest/get_company?id=5835"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbaxter-quality-sme-production-process-controls"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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%2Fbaxter-quality-sme-production-process-controls"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Fbaxter-quality-sme-production-process-controls"},{"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/baxter-quality-sme-production-process-controls\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbaxter-quality-sme-production-process-controls"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4167020}},{"tool":"search_jobs","arguments":{"company":"baxter.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4167020},"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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