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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. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's 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.
The 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 operations
- Plans and schedules the work of Quality Associates I and II
- Interview, hire, train, and evaluate QALO personnel. Ensures all QALO oversight tasks are properly completed and documented
- Reviews all risk assessment results and ensures compliance
- Ensures compliance with all federal, state, local and company-specific regulations related to quality of product and employee safety
- Tracks and trends Quality data for review and reporting
- Create and review Failure Investigation Reports for deviations and/or non-compliance issues that occur during production activities
- Works closely with Production Supervision, Technical Services, and Engineering to ensure adequacy and appropriateness of parameters, product specifications, and overall cGMP compliance
- Lead change control activities/documentation such as validation change control documents, work orders, Hold requirements, etc
- Develops 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 observations
- Represent QALO during client audits and regulatory inspections as needed. Provide information as needed to auditors that establishes credibility and demonstrates compliance with cGMPs
- Authors Nonconformance Reports and corrective and preventative action responses
- Performs quality review of Nonconformance Reports, procedures, risk assessments/static pressure events, environmental chamber charts, MBR/MSS/LMR and SOP revisions, and validation documents as necessary
- Provides technical support and guidance to Nonconformance Report authors
- Leads cross functional continuous improvement project teams applying Lean principles
Job Requirements (Education and Experience)
- Bachelor's degree (in a science field preferred)
- 3 years of proven experience in Pharmaceutical Quality or Manufacturing,
- Knowledge of aseptic manufacturing processes preferred.
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
Physical / Safety Requirements
- Must wear appropriate PPE as the need arises for various manufacturing areas
- Must be able to gown qualify for Grade A/B areas.
- Duties may require overtime work, including nights and weekends
- Use of hands and fingers to manipulate office equipment is required
- Position requires sitting for long hours, but may involve walking or standing for periods of time.
The 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 Opportunity
Baxter 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 Law
EEO is the law - Poster Supplement
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