Sumitomo Pharma America, Inc. · 3 hours ago
Quality Assurance Specialist II
Morrisville, NC
Full-time
Onsite
Entry, Mid Level
$84K/yr - $105K/yr
2+ years expSumitomo Pharma America, Inc. is a global pharmaceutical company focused on addressing patient needs in various therapeutic areas. The Quality Assurance Specialist II will provide oversight during aseptic manufacturing operations and ensure compliance with regulatory requirements, company procedures, and quality systems.
Pharmaceuticals
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 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
Qualification
Required
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
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
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
Demonstrated success in a quality role(s) in the pharmaceutical or biologics industry
Benefits
Opportunity for merit-based salary increases
Short incentive plan participation
Eligibility for our 401(k) plan
Medical, dental, vision, life and disability insurances
Leaves provided in line with your work state
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
Company
Sumitomo Pharma America, Inc.
Sumitomo Pharma America (SMPA) is a science-based, technology-driven biopharmaceutical company focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need in oncology, urology, women’s health, rare disease, cell and gene therapies and CNS.
Founded in 2023Marlborough, Massachusetts, US
1001-5000 employeesH1B Sponsorship
Sumitomo Pharma America, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (9)
2023 (14)
Funding
Current Stage
Late StageLeadership Team
Adele Gulfo
Chief Executive Officer, Biopharma Commercial
Myrtle Potter
President and Chief Executive Officer, Sumitomo Pharma America
Company data provided by crunchbase