Quality Control Analyst II

Sumitomo Pharma • Morrisville, NC

8d • $68,700 - $85,900 • Onsite

About The Position

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://www.us.sumitomo-pharma.com or follow us on LinkedIn. Job Overview We are currently seeking a dynamic, highly motivated, detailed oriented and experienced individual for the position of Quality Control Analyst II. The Quality Control Analyst II plays an essential role in ensuring the safety, quality, and compliance of products by performing routine QC assays, environmental monitoring, and supporting validation activities in a fast‑paced, regulated environment. Reporting to the Senior Manager of Quality Control, this role supports critical QC testing activities for tissue- and cell-based product manufacturing. The position is fully on‑site and follows a 12‑hour shift schedule (Sunday–Wednesday or Wednesday–Saturday, 7:00 AM–7:00 PM).

Requirements

• Strong experience in aseptic technique and microbiology best practices.
• Ability to work independently during shift hours while collaborating effectively with cross‑functional partners.
• Comfortable wearing full cleanroom gowning for extended periods.
• Exceptional attention to detail and commitment to data integrity.
• Demonstrated ability to work safely and responsibly in laboratory and manufacturing environments.
• Capable of identifying compliance, environmental, safety, and process deviations, and escalating issues appropriately.
• Regular standing, walking, and sitting; occasional lifting of 20–25 pounds.
• Capable of identifying compliance, environmental, safety, and process deviations, and escalating issues appropriately.
• Bachelor's degree in Chemistry, Microbiology, Biological Sciences, or a related discipline.
• Minimum of 3+ years of Quality Control experience in the biotechnology or pharmaceutical industry.

Nice To Haves

• At least 1 year of hands‑on experience with PCR or ELISA.

Responsibilities

• Perform routine raw material, in-process, and final product testing, including-but not limited to-BacT sterility testing, endotoxin testing, ELISA, and qPCR
• Conduct environmental monitoring (EM) of ISO 7 and ISO 8 cleanrooms, biosafety cabinets (BSCs), isolators, and other controlled support areas.
• Support method and process validation/verification activities under guidance from senior laboratory personnel.
• Participate in laboratory and environmental monitoring investigations, including root‑cause analysis and corrective action support.
• Generate accurate, timely, and compliant data to support development, manufacturing, and release of investigational and commercial products.
• Maintain laboratory inventory, cleanliness, and readiness in accordance with cGMP and safety standards.

Benefits

• Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, overtime, 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 up to 120 hours of vacation per year, 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 and access to our service recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level