Quality Control Analyst II

Quality Control Analyst II - MicrobiologyThe Quality Control Analyst II is responsible for maintaining high standards of laboratory operations and ensuring compliance with regulatory requirements. Key responsibilities include:Performing microbiological validations for raw materials and finished products, including Bioburden, Endotoxin, Sterility, and PET.Providing support to QC Microbiology laboratories.Conducting equipment qualifications.Organizing and assisting with Media Fill and Reads.Identifying ongoing quality issues, preventing potential problems, and suggesting improvements.Interpreting and evaluating analyses for accuracy and precision against established specifications, recommending and implementing corrective actions when necessary.Potentially responsible for analytical and protocol report writing, as well as standard operating procedures.Strictly adhering to Good Documentation Practices (GDP).Collaborating with and supporting coworkers to enhance the organization's overall capabilities.Communicating effectively with production, maintenance, warehouse, and other relevant functions.Participating in problem-solving and troubleshooting.Supporting training needs of team members and working cohesively with the team.Coordinating with and supporting other departments to ensure smooth workflow execution.Ensuring the availability of supplies and equipment to meet schedules and carrying out tasks as defined by the schedule.QualificationsBachelor's Degree or equivalent years of related experience (or high school 8 yrs; Assoc. 4 yrs).The ability to fluently read, write, understand, and communicate in English.Desired CompetenciesStrong knowledge of pharmaceutical regulatory requirements.Excellent communication skills, in both verbal and written form.Highly attentive to details and comfortable speaking up.Self-starter with the ability to follow up on and complete multiple projects simultaneously with little direction.Able to work overtime and flexible work hours to meet department goals.