Microbiologist II

The Microbiologist II performs Quality laboratory microbiological analyses of materials including water testing, finished product testing, raw material testing, and method validation. Supports laboratory investigations of moderate scope and complexity while abiding by GMPs and GLPs. Has working knowledge of, and stays current with, regulatory guidance and compendia relevant to laboratories and pharmaceutical manufacturing.All incumbents are responsible for following applicable Division & Company policies and procedures.Microbiology LabConducts microbiological analyses: water testing, finished product testing, raw material testing, environmental monitoring, media preparation, method verification and validation, and identification of microorganismsPerforms day-to-day operations of the Microbiology Lab to ensure that cGMPs, GLP’s and all other applicable compendia requirements are met Schedules monitoring and samples for testing/inspection, reviews data and ensures monitoring, testing, and inspection is completed per approved proceduresReviews test data and ensures testing is performed based on approved proceduresMay review testing/inspection results and disposition incoming/in process/finished productMay perform pour plates techniques, membrane filtration, and pure culture isolationRecords results from tests, interprets colony morphology, and accurately maintains laboratory dataElevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends corrective actions65%SOPsValidates/qualifies test procedures and equipment used for various testing/inspection activities performed by QualityReviews and updates SOPs and procedures for Quality as needed Reviews and comments on the articles affecting Quality in the USP Supplements and Pharmacopeial ForumsOversees maintenance, logbooks, and expiration dates of stock cultures, media, and sterilization documents15%Compliance & InvestigationsMay perform gap assessments for procedures for the various Quality programs (EM, incoming/in process/ finished product Inspection, component/raw material/product review and disposition) to ensure cGMP complianceSupports laboratory investigations of moderate scope and complexity while abiding by GMPs and GLPs Assists in performing microbiological audits of facilitiesFollows internal processes related to controlled substances10%Lab EquipmentMaintains laboratory equipment in clean order; reports equipment problems to SupervisorPerforms laboratory equipment qualificationsLearns to troubleshoot basic instrument problems5%TrainingDemonstrates responsibility in training others in good documentation practice, practical lab skills, and microbiological theories, methodologies and proceduresMaintains assigned training records current and in-compliance5%SafetyFollows EH&S procedures to ensure a safe work environmentFollows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDSContinuousQualificationsEducation & ExperienceMinimal acceptable level of education, work experience and certifications required for the jobBachelor of Science degree in microbiology, biology or related field with 2+ years’ relevant microbiology laboratory experience ORMaster of Science degree in above disciplines with 1+ year’ relevant pharmaceutical lab experience preferredKnowledgeProficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.Demonstrated proficiency with microbiology techniques and instrumentsDemonstrated competence in conducting microbiological analysesKnowledge of regulatory guidance and compendia relevant to laboratories and pharmaceutical manufacturingKnowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDSCompetency in Microsoft Office SuiteKnowledgeable in aseptic techniquesSkills & AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.Ability to display and analyze data in a logical mannerGood verbal and written communication skills as well as good computer skillsAttention to details and accurate record keepingAbility to establish and maintain cooperative working relationships with othersSolid organizational skillsAbility to take initiative, set priorities and follow through on assignmentsPhysical RequirementsExtended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicalsMust occasionally lift and/or move up to 15-25 lbs.Ability to wear personal protective equipment, including respirators, gloves, etc.. Specific visions abilities are required by this job include close vision and color vision.Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.The work environment is representative of a group laboratory environment.