Quality Assurance Specialist II

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner.

For more information on SMPA, visit our website https://(Use the "Apply for this Job" box below). Description We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Quality Assurance Specialist II reporting to the Senior Manager Quality Assurance of Cell Quality Operations in Morrisville, NC. This role requires independent work on site on 2-2-3 shift to support GMP operations on alternating shifts (Sunday – Thursday 7:00 AM to 7:00 PM and Friday – Saturday 7:00 – 5:00PM) that includes weekends on a rotating basis, as the manufacturing process is a 7-day process.

This role requires frequent work in cleanroom environments and a strong understanding of aseptic techniques and compliance standards.

A successful candidate will have relevant experience in early stage and/or commercial cell-based products manufacturing, shop floor support in an aseptic manufacturing environment. The Quality team at Sumitomo Pharma America, Inc. takes pride in leading compliant and innovative approaches to the development and commercialization of life-saving therapies. Quality Assurance (QA) Specialist II will be a key member of our growing Quality Operations team, and support the Quality Systems, Quality Control and Quality Compliance functions.

The ideal candidate is dedicated to excellence, passionate, adaptable, innovative, and eager to work in a collaborative environment.

This candidate will be an integral member of a growing Quality team and work closely with our cross-functional development team and external partners. Critical responsibilities include ensuring compliance with regulatory requirements, company procedures, and supporting the build-out and continuing maintenance of our regenerative medicine manufacturing facility. This candidate must have demonstrated success in a quality role(s) in the pharmaceutical or biologics industry.

Job Duties and Responsibilities Provide Quality and Compliance oversight during aseptic manufacturing operations for manufacturing commercial and investigational products through Shop Floor presence.

Conduct thorough reviews of logbooks and Work Orders across Manufacturing, Engineering, Quality, and Warehouse departments to ensure entries are complete, accurate, and compliant with company policies and procedures.

Experienced in aseptic operations within isolators, incubators, and biosafety cabinets (BSC), with knowledge in sterilization and decontamination cycles

Responsible for providing QA review/approval of the completed Manufacturing batch records in a timely manner and ensuring that the entries adhere to the company policies and procedures.

Lead or participate in investigations and improvement activities and experience using tools, such as - 5 whys, Fishbone analysis.

Review and verify maintenance and calibration records in BMRAM and collaborate with engineering and maintenance teams to resolve discrepancies.

Ensure isolator operations are performed in compliance with validated procedures and aseptic techniques.

Advise and direct on the interpretation and implementation of regulations, guidelines, company procedures, and standards for the SMPA Quality Management System.

Ensure a state of inspection readiness at our internal manufacturing facility; provide Quality support and audit management during Agency inspections.

Support the SMPA Quality Management System, including but not limited to processes for Document Management, Deviations, CAPA, Change Control, Complaints, Management Review, Validation and Data Integrity.

Performing inspection and disposition of raw materials and components by supporting incoming material release activities within the ERP system, ensuring compliance with applicable…