Senior Microbiologist at Gandiva Insights

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 Strong knowledge of microbiology in a pharmaceutical QC environment. Experience with EM programs sterile manufacturing and cGMP compliance. Skilled in deviation investigations CAPA OOS/OOT handling and root-cause analysis. Ability to train staff manage lab operations and oversee equipment qualification. Strong documentation communication and problem-solving skills. Key Skills Laboratory Experience,Virology,FDA Regulations,Infusion Experience,Laboratory Procedures,PCR,Biotechnology,Microbiology,Quality Control,GLP,cGMP,QA/QC Employment Type : Full Time Experience: years Vacancy: 1