Join Our Team! Children’s GMP, LLC is hiring for the role of Sr Quality/Prod Specialist within the Quality Control Department. The person in this role will work independently to assess environmental conditions in the GMP and lead the Environmental Monitoring (EM) Initiative for Children’s GMP, LLC, in order to maintain cGMP clean room environment compliance in accordance with FDA regulatory requirements and ICH guidelines for biopharmaceutical products. The GMP facility plays a critical role in moving promising discoveries from St. Jude laboratories into our clinics, ensuring that biopharmaceuticals and other biological products for patient use are manufactured in accordance with strict federal regulations. To thrive in this role, the ideal candidate for the Senior Quality/Production Specialist position will be protocol-oriented, highly organized, and reliable. This individual will be responsible for coordinating and executing all weekly routine monitoring activities, making familiarity with project management software for tracking these activities and subsequent environmental monitoring (EM) results highly desirable. The ideal candidate will possess excellent written and verbal communication skills, enabling them to relay environmental monitoring findings clearly and promptly to QC management and other GMP teams. They will also be responsible for efficient documentation completion, writing excursion reports, and making significant contributions to the development and implementation of the Environmental Monitoring Initiative. Additionally, they will be involved in writing, reviewing, and editing Standard Operating Procedures, as well as communicating effectively with vendors. Previous experience in Environmental Monitoring is strongly preferred, and a background in microbiology is advantageous for this role. Key Responsibilities: Maintaining the Routine Environmental Monitoring Schedule and sampling plan. Maintaining the Environmental Monitoring Equipment. Leading Environmental Monitoring Related Investigations and Writing Excursion Reports. Scheduling Operational/Dynamic Environmental Monitoring During Product Manufacturing. Training Others to Perform and Use Environmental Monitoring Equipment. Trending the Microbiological Results of the Routine EM Sampling. Writing and Providing the GMP Facility Microbiological Annual Status Report. Writing Room Status Reports. Monitor and document compliance with quality and regulatory requirements. Guide/make recommendations for continuous improvement of production/quality/ compliance systems using documentation such as release specifications, variances, environmental monitoring reports, and internal audits. Communicating ALL Out of Trend or Excursion Events That Reach Alert/Action Limits to Children’s GMP, LLC Management Other QC activities as required. Maintains regular and predictable attendance. Minimum Education: Bachelor's degree in chemistry, biology or a related field required. Master's degree preferred. Minimum Experience: Experience working with quality/production systems/processes and their maintenance/implementation, as applicable to own area (e.g. cell processing, cell culture, vector production) preferred. Experience working with quality/manufacturing regulations and guidelines (e.g., cGMP, cGTP, FACT) preferred. Experience working with electronic systems commonly used in Quality Management Systems, preferred as applicable. Experience working with computerized databases preferred as applicable. Proven performance in earlier role/ comparable role. Compensation In recognition of certain U.S. state and municipal pay transparency laws, St. Jude is including a reasonable estimate of the compensation range for this role. This is an estimate offered in good faith and a specific salary offer takes into account factors that are considered in making compensation decisions including but not limited to skill sets, experience and training, licensure and certifications, and other business and organizational needs. It is not typical for an individual to be hired at or near the top of the salary range and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range is $65,520 - $114,400 per year for the role of Sr Quality Control Specialist- Children’s GMP. Explore our exceptional benefits! Diversity, Equity and Inclusion St. Jude Children’s Research Hospital has a diverse, global patient population and workforce, built on the principles of diversity, equity and inclusion. Our founder Danny Thomas envisioned a hospital that would treat children of the world—regardless of race, religion or a family’s ability to pay. Learn more about our history and commitment. Today, we continue the mission to advance cures and means of prevention for pediatric catastrophic diseases through research and treatment. As we accelerate this progress globally, we believe our legacy of diversity, equity and inclusion is foundational to success. With the commitment of leaders at all levels of the organization, we strive to ensure the St. Jude culture, leadership approaches and talent processes are equitable and culturally responsive. View our Diversity, Equity and Inclusion Report to learn about the hospital’s roots in diversity, equity and inclusion, where we are today and our aspirations for an even better future. St. Jude is an Equal Opportunity Employer No Search Firms St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.