Quality SME, Production & Process Controls Marion, NC

Job description

Apply Now Overview This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives. • Support for Parents • Continuing Education/ Professional Development • Employee Health & Well-Being Benefits • Paid Time Off • 2 Days a Year to Volunteer Success Profile What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit. • Detail Oriented • Continuous Learner • Courageous • Collaborative • Critical Thinker • Influential Quality SME, Production & Process Controls Apply Now This is where your work makes a difference. At 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. Our 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. Here, you will find more than just a job—you will find purpose and pride. Your Role at Baxter This is where your creativity addresses challenges You 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. Your Team at Baxter Within 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. The 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. The 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. We 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. What you'll be doing • Serve 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. • Provide 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. • Provide 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. • Provide 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. • Provide 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. • Support all sites in sustaining an Always Inspection Ready state through risk-based assessments, readiness reviews, mock inspections, coaching, and timely closure of identified gaps. • Provide 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. • Lead 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. • Independently 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. • Perform and lead risk-based assessments of manufacturing operations, process control systems, production practices, manufacturing documentation, and operational execution. • Review and challenge manufacturing-related deviations, investigations, process excursions, batch failures, human error events, repeat deviations, and product impact assessments. • Evaluate process control strategies, in-process monitoring programs, alarm management practices, and manufacturing controls to ensure consistent product quality and process robustness. • Provide technical compliance guidance on site-owned remediation plans addressing manufacturing compliance gaps, process weaknesses, recurring deviations, and inspection observations; review their adequacy and effectiveness. • Assess 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. • Provide 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. • Partner with site leadership to improve investigation quality, root cause analysis, CAPA effectiveness, and operational ownership of compliance issues. • Conduct site assessments, manufacturing system reviews, gap analyses, and mock inspections to identify vulnerabilities and opportunities for improvement. • Monitor manufacturing compliance performance, recurring trends, process capability indicators, and operational risk signals, escalating significant concerns as necessary. • Coach and mentor manufacturing, quality, and technical personnel on production controls, process discipline, GMP expectations, and regulatory requirements. • Interpret current regulatory expectations and industr