Quality - QC Associate

Quality Control Associate

Location:

Bothell, WA - 100% onsite

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Skills:

• Bachelor's degree in life or physical sciences
• Strong analytical and communication skills
• Computer proficiency as well as the ability to master new software programs
• The ability to work effectively with others
• Experience working in a GMP environment is preferred

The primary focus of the Quality Control Associate I role will be to support raw material testing and release within a cGMP environment.

Required Competencies:

Education:

• BS in a scientific discipline

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

Duties and Responsibilities:

• Perform or support cGMP Raw Material release testing using various software packages
• Perform visual inspection on incoming materials
• Submit raw material testing samples to testing sites
• Generate certificates of analysis for materials ready for release
• Gas Identity testing using Drager tubes
• Vendor certificate review
• Ensure timely completion of testing and tasks as assigned
• 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