New

Quality Training Coordinator

Koch Business Solutions, LP
life insurance, parental leave
United States, Wisconsin, Hudson
May 24, 2025
Your Job Phillips-Medisize, a Molex company is seeking a GMP Quality Training Coordinator to support our operations in western Wisconsin. This role requires a robust understanding of FDA, EMA, and other regulatory requirements, along with a proven track record in developing compliance-based training programs, within the medical device or pharmaceutical industry. This is a hybrid position that can be based out of Hudson, New Richmond, or Menomonie depending on where the individual resides. Our Team The largest RCP, pharmaceutical, MedTech and in-vitro diagnostic companies in the world count on Phillips-Medisize to bring their breakthrough ideas and innovative branded products to market - with confidence. As a contract design and manufacturing organization (CDMO), we work closely with our customers to deliver proven, highly engineered products that help millions of people live healthier, more productive lives. Autoinjectors and pens for delivering insulin, GLP1, epinephrine and other life-saving drug treatments. Advanced, wearable injection pumps. Point-of-care and at home diagnostic tests. Electrophysiology technology. Continuous glucose monitoring systems. Our team at Hudson, WI is made up roughly of 300 employees that support our Production, Engineering, Quality, Molding & Tooling departments. What You Will Do Design and implement comprehensive GMP training programs focused on compliance, quality assurance, and regulatory standards. Manage and maintain the electronic Training Management System to track employee training completions and compliance status. Partner with Learning and Development team mebers, QA, QC, Manufacturing, and Regulatory to identify and address training needs. Regularly assess and enhance training programs based on feedback, audits, and performance evaluations. Generate and analyze training data to identify trends, gaps, or areas of non-compliance, supporting continuous improvement initiatives. Maintain accurate documentation of all training activities and ensure compliance with regulatory requirements. Who You Are (Basic Qualifications) Bachelor's degree in Life Sciences, Chemistry, Biotechnology, or a related field. 5+ years of experience in a cGMP environment, focusing on training management in the biotech, pharmaceutical, or related industries. Experience with electronic Training Management Systems (TMS) in regulated environments. Familiarity with both traditional and modern instructional training methods and techniques. What Will Put You Ahead Background in quality assurance, quality control, or compliance training. Strong analytical and problem-solving skills. Project management skills with the ability to manage multiple priorities in a dynamic environment. In-depth knowledge of cGMP, biopharmaceutical manufacturing operations, and quality systems. This position does not qualify for VISA Sponsorship. In order to comply with U.S. export control laws and regulations, this position requires applicants to either provide proof of U.S. citizenship or lawful permanent resident status or be eligible to receive an export authorization (a license) under the International Traffic in Arms Regulations and/or the Export Administration Regulations. At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy. Hiring Philosophy All Koch companies value diversity of thought, perspectives, aptitudes, experiences, and backgrounds. We are Military Ready and Second Chance employers. Learn more about our hiring philosophy here. Who We Are As a Molex company, Phillips-Medisize mobilizes and deploys specialized capabilities and services across highly regulated industries, including health care, regulated consumer, automotive and defense. We design, develop and create innovative and life-changing medical technologies for millions of people around the globe. At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company. Our Benefits Our goal is for each employee, and their families, to live fulfilling and healthy lives. We provide essential resources and support to build and maintain physical, financial, and emotional strength - focusing on overall wellbeing so you can focus on what matters most. Our benefits plan includes - medical, dental, vision, flexible spending and health savings accounts, life insurance, ADD, disability, retirement, paid vacation/time off, educational assistance, and may also include infertility assistance, paid parental leave and adoption assistance. Specific eligibility criteria is set by the applicable Summary Plan Description, policy or guideline and benefits may vary by geographic region. If you have questions on what benefits apply to you, please speak to your recruiter. Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results. Equal Opportunities Equal Opportunity Employer, including disability and protected veteran status. Except where prohibited by state law, some offers of employment are conditioned upon successfully passing a drug test. This employer uses E-Verify. Please click here for additional information. (For Illinois E-Verify information click here, aqui, or tu).