Cleanroom Microbiologist

Cleanroom Microbiologist Boca Raton, FL Job Details Full-time $31.25 an hour 1 day ago Qualifications Microbiology EHS Procedural guides ISO standards Compliance audits & assessments GMP Mid-level Microbiology Quality assurance audits Collecting samples for laboratory testing Bachelor's degree Laboratory quality control Laboratory techniques Batch records Data interpretation Cleanroom Environmental monitoring Microbiological analysis Quality audits Sterile laboratory techniques Bachelor's degree in microbiology 2 years Manufacturing company experience Communication skills Full Job Description Education and Preferred Qualifications A bachelor's degree in microbiology or related science is required. Candidates should have more than 2 years of experience in a cGMP lab environment in the pharmaceutical industry. Summary Statement The Cleanroom Microbiologist will be responsible for performing environmental testing in the cleanrooms and conducting trend analysis as needed. The cleanroom microbiologist will be working closely with our Microbiologist and QC specialist. Responsibilities Conduct environmental testing necessary for the cleanroom (ISO7 and ISO8 suites) Evaluate and interpret the results of analytical and microbiological testing. Support the Cleanroom Microbiologist with data interpretation and analysis Collect microbial samples as required. Trend results for monitoring and decision-making actions. Responsible for comprehensive recording of test results. Participate in all aspects of cleanroom out-of-specification, deviations, and contamination event investigations. Ensure that the necessary microbiology tests are done according to the test specification, test method, and working instruction, and ensure on-time release for cell products. Complete all required documentation (including, but not limited to, batch records, logbooks, raw data (charts, graphs, scans, etc.), validation protocols, and cGMP-related forms. Maintain a clean, organized laboratory environment, including daily logs and sample tracking Serve as the author of reports for GOL cleanrooms. Performs data compilation, reviews, and performs trend analysis on production processes and possible deviations when required. Work closely with the QA department and participate in internal and external audits Supports all lab-related tasks Provides support for projects by attending and participating in team meetings Participates in projects and task forces jointly with production personnel in case the need arises. Flexible working hours to support production. Other duties as assigned by the manager Knowledge, Skills, and Experience Experience with cGMP standards, SOPs, Environmental Health & Safety, and Quality requirements and applicable regulations- maintain awareness of industry best practices Extensive experience with aseptic techniques Experience in manufacturing and quality in the pharmaceutical industry, preferably in cell therapy. Familiarity with standard concepts, practices, and procedures in the field of microbiology Experience with aseptic gowning, environmental monitoring, sterility testing, and bacterial endotoxin testing Capacity to review and analyze data Experience defending laboratory practices in regulatory audits Excellent written communication skills in order to author SOP's, Work Instructions, policies, forms, and other documents Good interpersonal skills Self-Starter, team player Ability to work in a fast-paced, controlled, cleanroom environment up to 8 hours a day with additional overtime as required. Ability to work in a cleanroom.