QC Specialist II

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Quality Control Specialist II. The Quality team at Sumitomo Pharma America, Inc. takes pride in leading compliant and innovative approaches to the development and commercialization of life-altering therapies. Sumitomo Pharma America, Inc. is building a regenerative medicine manufacturing facility in Morrisville, NC to support both commercial and clinical needs, and the Quality team is growing significantly. We are looking for a Quality Control Specialist II to join our team and support our Quality Control functions. The ideal candidate will be passionate, innovative, dedicated to excellence and high performance, and eager to work in a collaborative environment. A demonstrated track record of success in the pharmaceutical industry and experience in Quality Control testing and environmental monitoring is expected. Importantly, we seek an aspiring professional with potential and desire to grow within the company.

The successful candidate will be an integral member of a growing Quality Control team and work closely with a cross-functional development team and external partners. Critical roles include performing environmental monitoring, executing method validation/transfer and performing release testing. This role will report to the Associate Director of Quality Control. Given the small company and dynamic nature of the work, the successful candidate must be agile and have strong interpersonal skills, with an ability to maintain focus on efficiently advancing innovative medicines addressing rare and often fatal diseases.

Job Duties and Responsibilities

• Perform routine raw material, in-process, and finished product release testing

• Perform environmental monitoring qualification and routine monitoring of the cleanrooms, biosafety cabinets (BSC), isolators, and other support areas

• Execute method qualification and validation with guidance from senior specialists/ management

• Support coordination of testing at external laboratories

• Support laboratory and environmental monitoring investigations

• Generate accurate and timely data to support development and release of investigational and commercial products

• Maintain oversight of laboratory inventory

Education and Experience

• B.S. / M.S. in Microbiology, biological or pharmaceutical sciences, or related discipline with at least 2 years related experience

• Experience with compendial methods such as endotoxin, sterility, and environmental monitoring is preferred

• Experience in ELISA and qPCR is a plus

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.

The base salary range for this role is $75,000 to $85,000. 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 unlimited 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.

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 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.

Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

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

Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All 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, gender identity or expression; 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.

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