Job: Microbiologist II (Quality Control), Mirus Consulting Group Corp, Wilson, NC
Experienced position in Quality Control Microbiology Laboratory and operation performing environmental Monitoring, Equipment Product contact as part of the EM program and Water system evaluation. Follows established standard operating procedures to assessing the microbiological laboratory results. Performs independent and collaborative tasks with the IQC team. Overseeing the Environmental program and Water System. Determine the appropriate action needed when excursions were obtained. Generate and work all investigations related to EM program and Water Monitoring. Provides support in generate reports assessment, protocols and SOPs. Demonstrates technical understanding of methodology, and discuss with external lab any situation with testing for all material submitted
Candidate must demonstrate strong technical understand of methodology and systems of quality for microbiological testing, scientific principles and practices. Support to identify potential root cause based in the ID Characterization when excursions were reported. Specific duties for the position to providing input for projects, training of other employees, knowledge of Laboratory testing and understanding EM program and Water monitoring systems. Provide EM and Water program support under minor supervision.
Collaborate with team members in any project needed giving input if any potential impact to EM program and Water trending.
Provide training of other employees on technical, cGMP, safety and administrative aspects of job. Serve as an informational/problem solving in Incoming Quality Control and pharmaceutical manufacturing systems for all related to microbiological support.
Carry out sampling of purified and potable water systems using aseptic techniques, as part of Water Monitoring program.
Overseeing the environmental monitoring program in operation, Non-Viable, Equipment Product Contact and Water System. Also, support areas using SAS volumetric and contact plate test applications. Support in sampling and perform all necessary arrangement with external laboratory to ensure samples and results are deliver on time.
Assessing the Water system results for microbiology test, review the on-line data results when needed and assessing any colony enumeration. Perform each quarter report and perform the trending evaluation.
Review the Quality Module and align the system with the corresponding Microbial Limits Testing when needed in the EM program. Also, any Pharmacopeia changes related to Microbial Limits Testing for any raw materials received in Wilson and products per USP methodology including total aerobic/yeasts and molds quantitative methodology and qualitative organism presence/absence tests need to be assessing to determine further action.
Review all the results received and performing the appropriate assessment to the identification characterization results. Lead and follow the appropriate process to identify the Root Cause in any deviation related to OOS, OOT results.
Lead consistently in productivity, quality and teamwork metrics.
Performs other duties as assigned.
Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.)
Education: BS, BA or Associates Degree in the sciences or related field, Master's degree
Languages: Fluent in written and spoken English
Experience: 2-4 years related experience