QC Analyst, Microbiology (Senior)
Kelly Science, Engineering, Technology & Telecom · Raleigh, NC · 1 wk ago
Science$35–$45/hrFull-time
Schedule: Monday–Friday, 8:00 AM–5:00 PM
Pay: $35–$45/hour (depending on experience)
About the role
A leading biotech organization is seeking a Senior Microbiology QC Analyst to support routine and investigational testing, environmental monitoring, data review, and implementation of GMP-compliant lab support systems. This role is hands-on in the lab and requires strong technical and operational knowledge of microbiological methods.
Responsibilities
- Perform cGMP microbial testing, including endotoxin, bioburden, and environmental monitoring
- Review raw data, perform peer or technical reviews, and authorize samples
- Lead and document lab investigations (IA, OOS, AR) with minimal guidance
- Author, review, and approve SOPs, technical reports, and validation documents
- Execute and support operational systems such as equipment calibration, data integrity, sample tracking, and LIMS
- Perform phase-appropriate method validation and provide data for regulatory filings and inspections
- Lead and support CAPA and continuous improvement initiatives
Requirements
- Bachelor’s degree in Microbiology or a related field
- 3+ years of experience in a cGMP/GxP environment
- Hands-on experience with bioburden, endotoxin, environmental monitoring, and facility qualification
- Experience authoring and reviewing SOPs and technical documentation
- Strong organizational and communication skills
- Self-motivated with the ability to thrive in a fast-paced, independent setting
Benefits
- Voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, and a legal plan
- Retirement savings plan
- Service bonus and holiday pay plans (earn up to eight paid holidays per benefit year)
- Transit spending account
- Paid sick leave under the applicable state or local plan