Senior Associate QA I - Second Shift (Tuesday through Saturday)

Role Summary

Senior Associate QA I - Second Shift (Tuesday through Saturday) at Amgen in New Albany, Ohio. This quality assurance role provides oversight for the GMP receiving area and is responsible for executing raw material inspection, sampling, and disposition activities to ensure compliant, timely release of materials for manufacturing. The position supports implementation of the quality management system within incoming quality and requires local presence at the New Albany facility near Columbus, Ohio.

Responsibilities

• Implement raw material sampling and inspection activities, including completion of GMP documentation to support raw material disposition
• Perform raw material disposition ensuring that all quality deliverables are met
• Provide quality expertise & guidance and work with operations partners, supply chain and supplier quality management to resolve issues and ensure timely release of the raw materials
• Own and review controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and Forms
• Own, investigate and approve quality records including deviations/CAPAs assuring adherence to procedural requirements and confirming assessments and evaluations of different collaborators are complete and accurate as needed
• Find opportunities for continuous improvement and implement improvements in partnership with other operations teams
• Provide support during GMP Quality audits & inspections
• Support Lean Transformation and Operational Excellence initiatives

Qualifications

• Required: High school/GED + 4 years of Quality and/or GMP Manufacturing experience
• Required: Associate’s + 2 years of Quality and/or GMP Manufacturing experience
• Required: Bachelor’s + 6 months years of Quality and/or GMP Manufacturing experience
• Required: Master's
• Preferred: Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies
• Preferred: Experience in and knowledge of GMP/GCP operations or similarly regulated industry
• Preferred: Affinity with digital innovation, data sciences and Quality engineering
• Preferred: Experience with raw material receipt, inspection & sampling
• Preferred: Highly effective verbal and written communication skills, strong interpersonal skills
• Preferred: Great attention to detail and high degree of accuracy in GMP documentation
• Preferred: Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues
• Preferred: Strong organizational skills, including ability to follow assignments through to completion
• Preferred: Direct experience with Enterprise Resource Management software (SAP), TrackWise, CDOCS etc.