P/T Analyst I, Quality Assurance

Welcome to DiscGenics, a pioneering, late-clinical stage biopharmaceutical company dedicated to advancing regenerative cell-based therapies for patients suffering from degenerative diseases of the spine. Privately held and passionately driven, our mission is to enhance lives by alleviating pain and restoring function through innovative treatment. At DiscGenics, we are committed to improving the quality of life for individuals debilitated by degenerative diseases of the spine. Our focus lies in developing cutting‑edge therapies that offer hope and tangible results, fostering a future where patients can regain mobility and comfort. Our team is characterized by a relentless pursuit of excellence and a nimble approach to addressing challenges. Our core values of Integrity, Innovation, Accuracy, Teamwork, and Stewardship guide everything we do. Join us at DiscGenics and be part of a transformative journey where your contributions have the potential to impact the lives of millions. Together we innovate with purpose and compassion, striving towards a future where pain and limitations of degenerative spine diseases are a thing of the past. Discover more about us at discgenics.com and see how you can contribute to revolutionizing patient care through regenerative therapies. Job Summary: This role is classified as part‑time, with an anticipated workload of 20-30 hours per week. Workdays are Monday through Friday, with scheduling flexibility depending on the selected candidate. The Analyst I, Quality Assurance is an entry level position and isresponsible for supporting the implementation and maintenance of the Quality Management System (QMS) to ensure compliance with regulatory requirements such as U.S. FDA regulations, 21CFR Part 11, and Good Manufacturing Practices. Assists in document control, nonconformance investigations, CAPA management, audit readiness, quality training management, compliance and regulatory support, and cross‑functional collaboration Provides support for environmental monitoring activities within the Manufacturing facility to ensure that operations remain in a state of compliance with applicable regulations for biologics including cell therapies. This role interacts with all levels of the organization. Delivers collaborative and positive leadership to facilitate department and organizational initiatives for cultural cohesion aligned to the DiscGenics Values. Essential Duties and Responsibilities: Supports other Departments in DiscGenics to enable quality by design. Supports the implementation of the Quality Management System (QMS) processes. Assist the internal audit program (internal and external). Conduct audits as needed. Assist the Corrective Action/Preventive Action (CAPA) Program. Ensure corrective actions are implemented effectively and timely. Assist the nonconformance program. Conduct investigations and root cause analysis. Conduct training on quality system processes, GMP and GDP. Assist in maintaining training program. Inspect product or review batch records. Conduct environmental monitoring (EM) throughout the manufacturing facility and assist in EM activities as needed. Create quality SOPs and templates and assist other functional areas in creating department specific SOPs and templates. Provide quality assurance support during manufacturing operations as needed. Other duties as assigned. Attends and contributes to technical team meetings. Job Requirements: Proficient with Microsoft Office, including Word, Excel and PowerPoint. Familiarity with relevant FDA, ICH, USP, AAMI, ISO guidelines and regulations associated with the quality control of aseptic processes, biologic/cell therapies in general and the environmental monitoring and operation of cleanrooms, specifically. Possesses high‑level of understanding of cGMP/GDP/GLP regulations. Experience with environmental monitoring programs and testing. Prior experience conducting contract laboratory audits. Strong interpersonal, communication (verbal and written), organizational, and project management skills. Exceptional time management, multi‑tasking, and organizational skills. Adheres to the Company Values of Integrity, Innovation, Accuracy, Teamwork, and Stewardship. Regular and predictable attendance. Ability to report to work unimpaired Education and Experience: Minimum of 2 years of Quality Assurance experience in cGMP environment or other regulated industry. Associate’s degree in biological sciences or related field preferred – or a combination experience and education. Prior experience in environmental monitoring in an aseptic manufacturing facility. cGMP manufacturing environment, Biologics and/or cell therapy environments preferred. Technical writing experience or aptitude. Working Conditions: Position requires qualified individuals to see, hear and speak (verbally and audibly). Required to ascend and descend stairs; sit, stand, lift, bend, stoop, crawl and kneel. The employee must also use hands to finger, handle or feel. Occasionally reaching with hands and arms, climbing or balancing are required. May be asked to drive or travel by car, air, or other transportation for business purposes. May be required to lift and carry up to 20 pounds. Must be able to function effectively with noise in a lab environment. Natural and regular stressors occur on the job. Disclaimer: Please note: DiscGenics reserves the right to change, modify, suspend, interpret, or cancel in whole, or in part, any of the duties outlined above, at any time, and without advance notice to the employee. #J-18808-Ljbffr DiscGenics, Inc.