BASIC QUALIFICATIONS:

• High School diploma/GED and 4 years of related GxP laboratory experience OR
• Associate’s degree and 2 years of related GxP laboratory experience OR
• Bachelor’s degree and 6 months of related GxP laboratory experience OR
• Master’s degree

PREFERRED QUALIFICATIONS:

• Experience working in a GMP pharmaceutical production facility with classified areas and applicable gowning requirements.
• Degree in Microbiology, Biology, Biochemistry, or related scientific field.
• Experience with microbiological quality control testing, including but not limited to: Endotoxin, Bioburden, Microbial Identification, TOC.
• Strong knowledge of aseptic technique.
• Experience with environmental monitoring and clean utilities’ monitoring, and trending of EM/utilities data.
• Proficient in Good Documentation Practices.
• Ensure precision in sample collection, data recording, and equipment handling.
• Strong written and verbal communication skills, including technical writing and technical presentations.
• Experience with equipment validation.
• Experience with method transfer, verification, and validation.
• Able to flexibly work independently, as a project owner, collaboratively on group tasks, and as a trainer.
• Experience owning, managing, and participating in deviations, CAPAs, and cross functional investigations.

Let’s do this. Let’s change the world. In this vital role you will be performing testing within the Quality Control Microbiology laboratory. Responsibilities will include sampling and testing to support clean utilities qualification and establishment of the environmental monitoring program to deliver site start up and then transition to testing in support of Amgen North Carolina commercial product release. Scope includes in-process, release, stability and routine monitoring testing. The Senior Associate Quality Control Microbiology will report directly to the Quality Control Specialist of Microbiology

• Assist with planning and execution of EMPQ activities to support establishment of environmental monitoring program.
• Support routine environmental monitoring and utilities sampling and testing.
• Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
• Collecting and preparing samples for analysis, ensuring proper labeling and documentation.
• Plan and execute routine sample collection for environmental monitoring in classified areas.
• Assist with planning and execution of clean utilities performance qualifications, including water for injection, clean steam, clean compressed air, oxygen, and carbon dioxide distribution systems.
• Execute sample collection for routine utilities’ monitoring.
• Assist with general lab maintenance activities and 5S.
• Perform routine tasks such as cleaning and inventory management.
• Support routine activities over the weekends and public holidays as required.
• Acting as a source of knowledge for all environmental monitoring & utilities monitoring areas
• Author, revise, and review documents and reports including but not limited to: SOPs, protocols, safety assessments, methods, trend reports, qualification/validation summary reports, microorganism assessments, technical reports, and method assessments.
• Oversight and Training of junior staff, including but not limited to creating and maintaining schedule for environmental and utilities monitoring.
• Own, manage, and participate in deviations, CAPAs, and cross functional investigations.