{"id":2978969,"url":"https://alion.io/job/mckesson-quality-operations-specialist","title":"Quality Operations Specialist","company":{"id":4393,"name":"McKesson","domain":"mckesson.com","url":"https://alion.io/company/mckesson","size_band":"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":32,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":12,"computed_at":"2026-10-22T06:10:10Z"}},"role":"Operations","role_family":"Operations","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Lakeland, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":100000,"max":105000,"currency":"USD","period":"year","gross":null,"usd_annual":105000},"salary_estimate":null,"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Gmail","optional":false},{"name":"Mandiant capa","optional":false}],"status":"live","first_seen_at":"2026-06-18T00:00:00Z","employer_posted_date":"2026-06-18","last_verified_at":"2026-10-23T02:41:24Z","board_verified":true,"closed_at":null,"days_open":127,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":126},"description":"McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care.\nWhat you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow’s health today, we want to hear from you.\nThe Quality Operations Specialist will serve as an individual contributor within the U.S. Pharmaceutical Distribution (USPD) Quality Team, providing quality and technical guidance to Operations. Reporting to the Senior Manager of Quality Operations, this role operates as a key contributor, independently and through project teams, to employ their knowledge and expertise to embed quality culture, reduce compliance risk, identify efficiencies, drive continuous improvement activities, and achieve business results. This role will ensure that processes, procedures, people, analytics and technology are being leveraged to maximize quality processes and compliance across the network.\nThe Quality Operations Specialist provides direction during high-risk and critical events that may have potential impact to product by applying their experience and judgement within defined policies. This individual will also influence investigation quality standards, documentation rigor, and work prioritization to promote consistent application of internal procedures and applicable regulatory requirements.\nIn addition, the Quality Operations Specialist supports the Senior Manager of Quality Operations in maintaining the effectiveness of USPD’s Quality Management System (QMS) in accordance with internal policies and applicable laws and regulations, including preparedness for emerging regulatory and operational changes. This role serves as an onsite technical resource to operational colleagues and cross-functional partners without formal people-management responsibility. Success in this role requires demonstrated expertise in regulated pharmaceutical distribution, strong analytical judgment, and effective collaboration across multiple internal and external stakeholders in a highly matrixed environment.\nThis is an onsite role located in Lakeland, FL (i.e. the Lakeland Pharma / FDC).\nCompensation: The target salary for this role is between $100,000 and $105,000.\nKey Responsibilities\nOperations Quality Support and Collaboration\nServe as the primary Quality liaison to Operations at the Lakeland DC\n\nMaintain a regular onsite presence to foster a culture of quality, compliance, and collaboration\n\nPartner with cross-functional stakeholders to address operational quality needs and risks\n\nPromptly escalate critical events while planning the investigative approach based on event risk, urgency, resource availability, and potential business impact\n\nOversees critical investigation execution, coordinating cross-functional input as needed to support timely and effective resolution\n\nQuality System Execution and Oversight\nDrive expectations for quality at the Distribution Center (DC) including, but not limited to:\nCreate, review and/or edit Standard Operating Procedures (SOPs) and Work Instructions (WIs) to enhance operational efficiency and compliance with corporate policies and regulations\n\nEnsure operational compliance with DSCSA and implementation of National Standards\n\nSupports the administration and completion of operational investigations, while coaching teams on root cause analysis tools, and the appropriate development and implementation of CAPAs to ensure regulatory defensibility.\n\nTranslates investigation data, trends, and business drivers into actionable recommendations that improve investigation outcomes and inspection readiness\n\nIdentifies operational pain points and emerging risks and translates them into system or procedural improvements while maintaining operational efficiency\n\nTechnical Resource Role\nServe as the Subject Matter Expert (SME) in the following areas:\nDocumentation Management / Version Control / Good Documentation Practices\n\nChange Control\n\nInvestigations / Root Cause Analysis\n\nCorrective and Preventive Actions (CAPAs)\n\nRegulatory Inspection Management\n\nValidation\n\nElectronic Quality Management Systems (e.g. TrackWise and MasterControl)\n\nData Integrity\n\nQuality Leadership, Coaching & Knowledge Development\nPartners with the site Director of Operations to support training delivery to enhance Operations’ understanding and application of Quality principles and requirements\n\nActs as a technical and process expert for less-experienced colleagues, providing guidance during critical events, and offering direction as appropriate without formal people-management responsibility\n\nAudit and Inspection Readiness\nSupport Operations to ensure continuous audit and inspection readiness\n\nAssist with inspection preparation activities and post-inspection responses as assigned\n\nParticipate in and support regulatory inspections, supplier/customer audits, and internal assessments as needed\n\nNOTE: This is not an all-inclusive list. Other duties may be required based on business need.\nMinimum Requirement\nDegree or equivalent and typically requires 4+ years of relevant experience.\nEducation\nBachelor’s degree in a scientific, technical, or quality-related field. Equivalent experience will be considered.\nCritical Skills\n3 - 5 years of progressive experience in pharmaceutical / medical device quality, or regulated distribution environments.\n\nKnowledge of cGMPs and Good Distribution Practices with a minimum of 2 years in a Quality Assurance role.\n\nExperience working in a large, matrixed organization with cross-functional exposure to Quality, Operations, Compliance, Technology, and external partners.\n\nAbility to conduct complex initiatives in a self-directed manner, with minimal oversight, and to deliver superior results in a timely manner.\n\nMust have excellent written and verbal communication skills to effectively communicate and influence a broad spectrum of business segment personnel and senior management.\n\nAbility to work effectively and professionally with internal and external personnel as a Quality ambassador.\n\nExcellent decision making and judgment capability.\n\nAbility to influence without formal authority.\n\nAbility to follow established procedures and instructions.\n\nSpecialized Knowledge & Skills\nKnowledge of FDA regulations and requirements applicable to pharmaceutical distribution, including the Code of Federal Regulations (21 CFR), Drug Supply Chain Security Act (DSCSA), and industry standards for temperature excursion management (e.g., USP , USP ).\n\nDemonstrates analytical, problem-solving, and decision-making skills, including interpretation of data and regulatory standards to support sound and regulatory-defensible conclusions.\n\nExperience contributing to CAPA development and execution, quality system enhancements, inspection readiness activities, and execution of regulatory-aligned investigation and documentation practices.\n\nPractical expertise working within an electronic Quality Management System (eQMS), including supporting investigation workflows, documentation standards, user enablement, and data integrity.\n\nExcellent prioritization skills to manage complex investigations and quality initiatives within a regulated environment.\n\nSupports development and implementation of policies and procedures related to regulated activities in the distribution centers.\n\nOversees the development and implementation of corrective action plans in response to findings from audits and other monitoring activities.\n\nProvide guidance in preparation for and during inspections by governmental agencies and monitors, and developing remediation plans.\n\nWorking Conditions\nEnvironment (Office, warehouse, etc.)\nRoutine onsite presence required in an office and distribution center environment.\n\nInteraction with warehouse operations as needed to support quality activities.\n\nAbility to travel domestically overnight 10% of the time.\n\nPhysical Requirements (Lifting, standing, etc.)\nGeneral office requirements, including extended periods of computer and keyboard use.\n\nAccess to warehouse environment and activities as needed.\n\nAbility to attend virtual meetings and training sessions.\n\nAbility to work in refrigerated environments for short periods of time to support quality activities.\n\nWe are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations.In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, please click here.\nOur Base Pay Range for this position\n$79,100 - $131,900McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson’s (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind:\nMcKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.\nMcKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.\nMcKesson job postings are posted on our career site: careers.mckesson.com.\nMcKesson is an Equal Opportunity Employer\nMcKesson provides equal employment opportunities to applicants and employees, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other legally protected category. For additional information on McKesson’s full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.\nMcKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to (United States)  or (Canada) . Resumes or CVs submitted to this email box will not be accepted.\nJoin us at McKesson!","description_format":"text","description_chars":10942,"description_truncated":false,"requirements":{"experience_years_min":4,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Pharmaceutical Distribution","Medical Equipment Distribution"],"lifecycle":[{"event":"open","at":"2026-10-21T06:09:54Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 107 · green card filings: 37","filings_12m":107,"filings_prev_12m":142,"green_card_filings_12m":37,"median_offered_wage_usd":152361,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+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":3,"band":"cold","label":"Long shot","p_open":1,"p_active":0.112,"p_room":0.28,"age_days":126,"expected_fill_days":12,"reasons":["conf:2","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-10-22T06:10:10Z"},"pay":{"stated_usd_annual":105000,"is_top_pay":true},"html_url":"https://alion.io/job/mckesson-quality-operations-specialist","json_url":"https://alion.io/job/mckesson-quality-operations-specialist.json","meta":{"generated_at":"2026-10-23T04:16:48Z","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":6975,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-24T00:00:00Z"}},"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":4393},"rest":"https://alion.io/mcp/rest/get_company?id=4393"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fmckesson-quality-operations-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%2Fmckesson-quality-operations-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%2Fmckesson-quality-operations-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/mckesson-quality-operations-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fmckesson-quality-operations-specialist"}]}