Quality Control Analyst II

Overview

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  or follow us on Linked In.

Job Overview:
We are currently seeking a dynamic, highly motivated, detail 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).

• 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 clean rooms, 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.

• 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.

Required:

• 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.

Preferred:

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

The base salary range for this role is $68,700 to $85,900. Base salary is part of our total rewards package which also includes 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 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.

Total compensation, including base salary, will depend on candidate experience, skills, education and other factors permitted by law.

Disclaimer:
The above statements describe the general nature and level of work performed by people assigned to this classification and are not to be construed as an exhaustive list of all responsibilities, duties, and skills required. All personnel may be required to perform…