Job DescriptionInsight Global is seeking a microbiologist to support a pharmaceutical client in Rahway, NJ. This microbiologist plays a crucial role in ensuring the microbiological integrity of pharmaceutical manufacturing areas and pharmaceutical products. This professional conducts thorough environmental monitoring to uphold regulatory standards in GMP-regulated spaces and should be well versed in EM protocols, investigations, and quality risk assessments. Additionally, qualified candidates should have experience in routine drug product testing. This position is on-site 5 days a week.Role and Responsibilities:MICROBIOLOGICAL PRODUCT ANALYSIS Analyze samples and compile meaningful data Perform Investigations and prepare/respond to CAPA Review, revise Test Procedures/Standard Operating Procedures Ad Hoc work Rotational on-call assignmentsMICROBIOLOGICAL ACTIVITIES Include (but not limited to): Receive, verify & Log in samples Return templates and shipping paperwork when and where appropriate Compile and trend data Prepare and ship materials offsite for ID/testing (when applicable) Environmental monitoring Stock culture management and quality control of same Biological indicator management Bioburden testing Water sampling Microbiological media management and quality control of same Sterilization activities Research experiments as deemed appropriate by client management Method Validation/Qualification Other microbiological activities Rotational on-call assignments for responding to alarmsGMP ACTIVITIES: Prepare GMP documentation as requested by management Perform laboratory sanitizations and ensure cleanliness of laboratory workspace Perform equipment sanitizations (incubators / hoods / refrigerators) Purchase supplies (GMP) Prepare and send documents to Records CenterWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com . To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Skills and RequirementsBachelor's degree in a scientific discipline (Microbiology or Biological Sciences preferredIn-depth knowledge of GMP standards and regulations1+ years of experience in the pharmaceutical industry in a microbiology related positionKnowledge of Environmental Monitoring practices (air, water, gas, utilities, surfaces)Experience with routine product testing (Bioburden, endotoxin, TOC)Ability to read and analyze EM and Product test results nullWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.
