QC Microbiologist II

Responsibilities

• Initiate OOS/OT or Environmental Monitoring Excursion Investigations
• Initiate Quality events such as deviations, invalid assay investigations, CAPA and Change controls.
• Perform microbiological testing (endotoxin, bioburden and TOC) for water
• Perform microbiological testing (endotoxin, sterility and bioburden) for raw materials, in-process materials, intermediates and final product
• Perform environmental monitoring of the clean rooms (under ISO and EU specifications)
• Read, trend and report environmental, personnel, in-process, raw material, finish product and water bioburden testing results
• Prepare and send out samples for microbiological identification
• Maintain historical files on organisms found in classified areas; microbial identification and trending
• Perform line clear and line start verifications
• Other tests as trained and assigned
• Receive QC microbiological sample for internal testing, login, processing, tracking, distribution of test results, and closure
• Aid QC management to author, review and approve documentation
• Aid QC management to perform Suite and PW system requalification
• Perform compendial testing such as pH, conductivity, and Osmolality etc.
• Support raw material handling and testing
• Provide Support of general QC Microbiology Laboratory activities, such as: Chart reading and changing, Equipment cleaning and maintenance, Maintaining supplies and inventory, General laboratory housekeeping

Qualifications

• Bachelor’s degree in a relevant field and a minimum of 3 years’ industry experience in a GMP, GLP, or pharmaceutical cleanroom environment, OR Master’s degree in a relevant field and 1 year of related work experience
• Preferred: Proficient in the validation/qualification of lab microbiological techniques, Knowledgeable in FDA cGMPs (21 CFR 211); ISO 9001, 13485 and 17025

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.