Microbiologist II

Role Overview This position involves executing quality control tasks to ensure product safety and compliance in a pharmaceutical manufacturing environment. Key Responsibilities Perform microbiological testing such as bioburden, endotoxin, microbial enumeration, Gram stain analysis, and growth promotion on raw materials, in-process, and finished goods.Coordinate sample submissions to external testing facilities and maintain laboratory inventory.Develop, optimize, and validate microbiological test methods; generate protocols, review data, and prepare reports.Revise SOPs, test methods, and procedures to ensure compliance with regulatory standards.Participate in validation activities involving aseptic processes and support environmental monitoring in cleanroom environments.Perform tests on high purity water samples and analyze environmental monitoring plates, including microbial identification.Assist in data review, trending, and report generation, and train new personnel.Adhere to FDA regulations and cGMP/cGLP documentation practices.Support aseptic process simulations, sterilization, and container integrity testing. Qualifications & Skills Bachelor’s degree in Microbiology or related field, with 2-4 years of relevant industry experience. Ability to work independently and prioritize tasks effectively. Strong organizational, interpersonal, and communication skills. Proficiency in MS Office and technical document reading. Physical ability to wear PPE, handle materials, and lift up to 25 pounds.