{"id":3940357,"url":"https://alion.io/job/baxter-qc-manager","title":"QC Manager","company":{"id":5835,"name":"Baxter","domain":"baxter.com","url":"https://alion.io/company/baxter","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":93,"open_postings":31,"ghost_share":0,"stale_share":0.419,"repost_share":0.097,"time_to_fill_p50_days":17,"computed_at":"2026-11-08T05:47:12Z"}},"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":["Jayuya, Puerto Rico"],"countries":["PR"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"GLP","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-08-19T00:00:00Z","employer_posted_date":"2026-08-19","last_verified_at":"2026-11-08T13:47:22Z","board_verified":true,"closed_at":null,"days_open":81,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":81},"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 Team\nAs the QC Manager, you will lead and organize the operations of the Microbiology and Chemistry Laboratories. You will work closely with Manufacturing, Supply Chain, Quality, Regulatory, and R&D teams to ensure laboratory testing activities are executed in compliance with FDA regulations, USP standards, company policies, and current Good Manufacturing Practices (cGMPs).\nThis role is responsible for the development and implementation of laboratory policies, systems, procedures, specifications, and testing programs for Raw Materials, In-Process Materials, Finished Products, Stability Programs, and Method Transfers. You will also oversee laboratory validation activities, quality monitoring programs, and change control processes to support business priorities, quality objectives, and operational excellence.\nWhat You'll Be Doing\nLaboratory Leadership & Operations\nDirect and manage all Microbiology and Chemistry Laboratory operations.\nCoordinate laboratory activities with Manufacturing and Supply Chain teams.\nLead, supervise, train, and develop exempt and non-exempt laboratory personnel.\nEnsure laboratory services are delivered efficiently, cost-effectively, and in compliance with applicable regulations and standards.\nPerform weekly, monthly, and annual reporting as required by site leadership and company procedures.\nQuality & Compliance\nEnsure compliance with all applicable FDA, USP, OSHA, EPA, cGMP, corporate, federal, and state requirements.\nEstablish, implement, and maintain laboratory standard operating procedures and policies.\nConduct and approve laboratory investigations, including root cause analysis activities.\nConduct trend analysis, including Annual Product Review data evaluations.\nEnsure all laboratory changes are appropriately managed through the change control system.\nMaintain accountability for the Product Stability Program.\nValidation & Method Transfer\nManage the laboratory validation program, including equipment, processes, test methods, software, and related systems.\nLead and support method transfer activities where applicable.\nParticipate in process validation and revalidation programs.\nOversee testing and analysis of validation samples.\nSupport continuous improvement initiatives through laboratory automation and testing method enhancements.\nTraining & Performance Management\nEnsure laboratory analysts are properly trained and qualified to perform testing activities.\nVerify adherence to Good Laboratory Practices, company standards, and regulatory requirements.\nRoutinely audit analyst performance, testing accuracy, and documentation practices to assess training effectiveness and compliance.\nBudget & Supplier Management\nDevelop and manage departmental operating and capital budgets.\nMaintain laboratory technologies, software, and equipment in an updated state.\nPrepare and submit capital expenditure requests as needed.\nEnsure all laboratory service contracts are maintained and current.\nEvaluate and manage laboratory maintenance service suppliers.\nWhat You'll Bring\nEducation & Experience\nBachelor's degree in Chemistry, Microbiology, or a related scientific discipline.\nMinimum of 8 years of experience in Quality Systems within a regulated environment.\nMinimum of 3 years of management or supervisory experience in a laboratory setting.\nExperience with wet chemistry and/or microbiology laboratory procedures.\nRoot Cause Analysis training and practical experience.\nWorking knowledge of applied statistics and statistical tools.\nStrong understanding of FDA regulations, USP standards, cGMPs, laboratory operations, and quality systems.\nExperience with laboratory validation programs, method transfers, and stabil\nProven ability to train, motivate, coach, and develop employees.\nStrong presentation and communication skills.\nDemonstrated success in change management and leading organizational change.\nDemonstrated commitment to integrity, accountability, teamwork, collaboration, and performance excellence.\nStrong facilitation and conflict resolution skills.\nLanguage Skills\nFully bilingual in English and Spanish.\nAbility to effectively communicate and present information to management, customers, and regulatory auditors.\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 Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter\nEqual Employment Opportunity\nBaxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.\nKnow Your Rights: Workplace Discrimination is Illegal\nReasonable Accommodations\nBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.\nRecruitment Fraud Notice\nBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. 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