Senior Microbiologist, NC

Job Title : Senior Microbiologist

Location : Raleigh, NC

Duration : Long-Term

Overview :

Seeking a Senior Microbiologist to support a QC Microbiology lab involved in sterile injectable manufacturing. This role handles complex microbiological testing, environmental monitoring (EM), deviations, OOS / OOT investigations, CAPAs, and daily QC lab operations in a fast-paced, FDA-regulated environment.

Key Responsibilities

• Perform and oversee microbiological testing and EM activities in compliance with cGMP, USP, and FDA standards.
• Lead deviation investigations, OOS / OOT reviews, and CAPA development.
• Maintain QC data, metrics, and tracking spreadsheets / databases.
• Manage lab inventory, ordering, and material issues.
• Serve as SME; train junior microbiologists in aseptic techniques, EM, and microbiological methods.
• Support qualification and maintenance of lab equipment; troubleshoot issues and ensure GLP compliance.
• Review GMP data, trend results, and identify risks or performance issues.
• Participate in method transfers, validations, and equipment IQ / OQ / PQ activities.
• Support audits, documentation updates, SOP improvements, and continuous improvement initiatives.
• Conduct data analysis and prepare reports, EM trend summaries, and investigation documentation.

Qualifications