Micro/EM Associate QC I
Amgen
July 01, 2026
On-site
Holly Springs, NC
Operations
Micro/EM Associate QC I
What You Will Do
- Perform testing within the Quality Control Microbiology laboratory, including sampling and testing to support clean utilities qualification and establishment of the environmental monitoring program for site start-up and transition to testing for North Carolina commercial product release.
- Scope includes in-process, release, stability and routine monitoring testing.
- Support document review and authoring (SOPs, safety assessments, methods, trend reports, microorganism assessments, technical reports).
- Assist with EMPQ activities; perform routine environmental monitoring and utilities sampling.
- Perform routine QC testing (Bioburden, Endotoxin, conductivity, TOC).
- Participate in audits, initiatives, and projects; participate in deviations, CAPAs, and cross-functional investigations.
- Assist with general lab setup and 5S; support routine weekend/public holiday activities as required.
- Assist with clean utilities performance qualifications (water for injection, clean steam, clean compressed air, oxygen, carbon dioxide systems).
- Perform routine tasks such as cleaning and inventory management.
What We Expect Of You
Basic Qualifications:
- High school/GED + 2 years related GxP laboratory work OR Associate’s + 6 months related GxP laboratory work OR Bachelor’s.
Preferred Qualifications/Skills:
- GMP pharmaceutical GMP experience (classified areas/gowning).
- Degree in Microbiology/Biology/Biochemistry or related field.
- Microbiological QC testing experience (Endotoxin, Bioburden, Microbial Identification, TOC, PCR).
- Aseptic technique; environmental monitoring and clean utilities monitoring.
- Proficient in Good Documentation Practices.
- Strong written/verbal communication (technical writing/presentations).
- Ability to work independently and collaboratively.
Application Instructions
- Apply via careers.amgen.com; anticipated application acceptance until May 8 (may continue beyond if needed).
What You Will Do
- Perform testing within the Quality Control Microbiology laboratory, including sampling and testing to support clean utilities qualification and establishment of the environmental monitoring program for site start-up and transition to testing for North Carolina commercial product release.
- Scope includes in-process, release, stability and routine monitoring testing.
- Support document review and authoring (SOPs, safety assessments, methods, trend reports, microorganism assessments, technical reports).
- Assist with EMPQ activities; perform routine environmental monitoring and utilities sampling.
- Perform routine QC testing (Bioburden, Endotoxin, conductivity, TOC).
- Participate in audits, initiatives, and projects; participate in deviations, CAPAs, and cross-functional investigations.
- Assist with general lab setup and 5S; support routine weekend/public holiday activities as required.
- Assist with clean utilities performance qualifications (water for injection, clean steam, clean compressed air, oxygen, carbon dioxide systems).
- Perform routine tasks such as cleaning and inventory management.
What We Expect Of You
Basic Qualifications:
- High school/GED + 2 years related GxP laboratory work OR Associate’s + 6 months related GxP laboratory work OR Bachelor’s.
Preferred Qualifications/Skills:
- GMP pharmaceutical GMP experience (classified areas/gowning).
- Degree in Microbiology/Biology/Biochemistry or related field.
- Microbiological QC testing experience (Endotoxin, Bioburden, Microbial Identification, TOC, PCR).
- Aseptic technique; environmental monitoring and clean utilities monitoring.
- Proficient in Good Documentation Practices.
- Strong written/verbal communication (technical writing/presentations).
- Ability to work independently and collaboratively.
Application Instructions
- Apply via careers.amgen.com; anticipated application acceptance until May 8 (may continue beyond if needed).