QC Associate

Location: Bothell
Posted on: June 23, 2025

Job Description:

Job Description: Job Title: QC Associate Location: Bothell, WA* 100% Onsite Schedule: Wed-Sat 06:00 - 4:30 The primary focus of the Quality Control Associate I role will be to support drug product lot release and in-process testing within a cGMP environment. EDUCATION - BS (Required) in Scientific discipline. Microbiology preferred. EXPERIENCE: 0-3 years of regulated industry experience, or equivalent combination of education and experience. Knowledge, Skills, and Abilities - Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects. - Strong analytical and communication skills. - Computer proficiency as well as the ability to master new software programs. - Experience working in a GMP environment is preferred. - Demonstrated success working in a high-performing, business results driven environment. RESPONSIBILITIES: - Perform or support cGMP lot release, in-process, and stability testing using various software packages. - Ensure timely completion of testing and tasks as assigned. - Support assay transfer and method validation of by executing cross-site validation protocols and providing data to support final reports. - Identify opportunities for continuous improvements. - Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. - Assist in the implementation of new assay methodologies and the associated instrumentation. - Identify and support initiation of Deviations, CAPAs and Laboratory Investigations. WORKING CONDITIONS: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. - Work in areas that may have strong magnets. - May work in areas with exposure to vapor phase liquid nitrogen. - Must have ability to work assigned shift (Day, Night, Weekends and/or holidays). - Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection. - Require to work in and around laboratories and controlled, enclosed, restricted areas, included clean rooms. - Require to carry and/or lift up to 10 pounds several times a day. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. Additional Job Requirements: Lab w/ blood & animal Position Handles Hazardous Materials

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