Quality Control Analyst 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  or follow us on Linked In.


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).

Job Duties and 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 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.

Key Core Competencies

• 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.

Physical Requirements:

• Regular standing, walking, and sitting; occasional lifting of 20-25 pounds.
• Capable of identifying compliance, environmental, safety, and process deviations, and escalating issues appropriately.

Education and Experience

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 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.

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.

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.

Compliance
:
Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that…