Quality Assurance Supervisor - Line Ops (3rd shift)

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxters products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.Join us at the intersection of saving and sustaining lives where your purpose accelerates our mission.SummaryThe Quality Assurance Supervisor Line Ops (QALO) is a member of the Quality Assurance Leadership Team reporting directly to the Quality Manager. They provide direct support to QALO and Manufacturing to ensure that finished products meet the required specifications by supervising QALO Associates I and II who provide quality oversight in the manufacturing areas. The QALO Supervisor provides decision making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Baxter Standard Operating Procedures. This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments. The QALO Supervisor creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned)Provides guidance, support, direction, and leadership through positive interactions with all personnel during daily operationsPlans and schedules the work of Quality Associates I and IIInterview, hire, train, and evaluate QALO personnel. Ensures all QALO oversight tasks are properly completed and documentedReviews all risk assessment results and ensures complianceEnsures compliance with all federal, state, local and company-specific regulations related to quality of product and employee safetyTracks and trends Quality data for review and reportingCreate and review Failure Investigation Reports for deviations and/or non-compliance issues that occur during production activitiesWorks closely with Production Supervision, Technical Services, and Engineering to ensure adequacy and appropriateness of parameters, product specifications, and overall cGMP complianceLead change control activities/documentation such as validation change control documents, work orders, Hold requirements, etcDevelops and maintains documentation procedures, QA instructions and department policy procedures. Ensures product compliance regulations are followed.Works in collaboration with management team to prepare for internal and external audits. Assists with timely closure of audit observationsRepresent QALO during client audits and regulatory inspections as needed. Provide information as needed to auditors that establishes credibility and demonstrates compliance with cGMPsAuthors Nonconformance Reports and corrective and preventative action responsesPerforms quality review of Nonconformance Reports, procedures, risk assessments/static pressure events, environmental chamber charts, MBR/MSS/LMR and SOP revisions, and validation documents as necessaryProvides technical support and guidance to Nonconformance Report authorsLeads cross functional continuous improvement project teams applying Lean principlesJob Requirements (Education and Experience)Bachelors degree (in a science field preferred)3 years of experience in Pharmaceutical Quality or Manufacturing,Knowledge of aseptic manufacturing processes puter proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)Physical / Safety RequirementsMust wear appropriate PPE as required for various manufacturing areasMust be able to gown qualify for Grade A/B areas.Duties may require overtime work, including nights and weekendsUse of hands and fingers to manipulate office equipment is requiredPosition requires sitting for long hours, but may involve walking or standing for periods of D-USOPSLI-LH1The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.Equal Employment OpportunityBaxter 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. EEO is the LawEEO is the law - Poster SupplementPay Transparency PolicyReasonable AccommodationsBaxter 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.Recruitment Fraud NoticeBaxter 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. To learn how you can protect yourself, review our Recruitment Fraud Notice. 074470

Created: 2025-09-06