Quality Assurance Specialist II

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.

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.

• 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 regulations and internal procedures.
• Complete additional tasks and responsibilities as assigned by the manager in a timely and professional manner.
• Coordinating with cross-functional teams to ensure proper disposition of released or rejected materials, including timely transfer to designated storage or quarantine areas.
• Conduct routine walkthroughs and detailed inspections of cleanroom areas to ensure compliance with GMP standards, identify potential contamination risks, verify proper gowning and material flow practices, and support continuous improvement of aseptic conditions

• Strong leadership skills
• Ability to work independently on shift and with cross functional teams
• Must be able to pass cleanroom gowning and aseptic technique qualification.
• Ability to work in cleanroom suit for extended periods.
• Flexibility to support off-shift or weekend operations as needed. High degree of organizational awareness, ability to connect the dots to understand interdependencies.
• Demonstrate honesty in all aspects of the role, and a commitment to compliance and respectful conduct.
• Familiar with isolator and BCS operations

• B.S. in chemistry, biological or pharmaceutical sciences, or related discipline is required.
• At least 2-5 years of industry experience in the biotech/pharmaceutical industry with focus on Quality/Manufacturing.
• Experience in a cGMP manufacturing environment, with strong working knowledge of FDA requirements and guidance documents.
• Experience in tissue and cell-based product manufacturing and aseptic techniques.
• Experience with isolator and BCS operations
• Relevant experience and knowledge of manufacturing, batch record review, and/or analytical analyses for the biotech/pharmaceutical industry.
• Proficiency in systems including KNEAT, Veeva, SAP, SlingShot, and BMRAM is highly desirable.

Travel Requirements:

Employees based onsite may need to travel domestically and/or internationally up to 10-25% of the time as required. Additional travel may be required for Management roles.

Mental/Physical Requirements:

1. Lifting and Carrying: Ability to lift and carry materials, including heavy items, as part of daily operations.

2. Standing and Walking: Prolonged periods of standing and walking

3. Manual Dexterity: Handling and operating equipment and tools.

4. Climbing and Reaching: Ability to climb ladders or steps and reach for items stored at various heights.

5. Environmental Conditions: Working in varying temperatures and handling materials in different environmental conditions.

The base salary range for this role is

$85,100.00 - $106,400.00

Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Drug Screening Requirements Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Sumitomo Pharma America (SMPA