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Quality Assurance Associate
4 months ago
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.