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Quality Assurance Associate

4 months ago


Bothell, United States Integrated Resources, Inc ( IRI ) Full time

TOP 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: Knowledge, Skills, and Abilities:

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.

Key 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.