QC Microbiology Lead

Under the direction of the Microbiology and Sterility Assurance Manager, the QC Microbiology Lead is responsible for the day-to-day operations of the QC Microbiology Laboratory. These duties include working with key stakeholders towards the best outcomes for the organization. The Lead will plan, direct and supervise the administrative activities of the QC Micro Lab. The Lead is responsible for evaluating material and product quality by performing various procedures in the Microbiology Laboratory and manufacturing facility. The QC Microbiology Lead role must possess the skills to interact with formulation, filling, validation, engineering, and packaging personnel in support of those functions. The qualified candidate will work with and guide the efforts of Microbiology Laboratory personnel to assure test results, procedures, and methods are written. The lead must have the ability to execute testing in a timely manner. The candidate must have the ability to work with a sense of urgency, assist with maintenance and analysis of Microbiological data, and work with other plant personnel to resolve problems related to actual or potential product quality problems. The Microbiology lead must have 5-6+ years of hands on pharmaceutical laboratory experience, and have the ability to work independently with minimal supervision. The Microbiology Lead will perform biological assays of commercial product raw materials, in-process samples, finished product, environmental monitoring samples, process & cleaning validation samples, components, as well as specialized techniques. Assays are qualitative, quantitative, and investigational in nature and are performed in compliance with USP, FDA and other regulatory body requirements. Results are compared with specifications and documented. The candidate will work with, and guide the efforts of Microbiology lab personnel to assure test results, procedures, and methods are written, maintained, executed, and approved in accordance with approved SOPs and regulatory documents. The candidate is responsible for maintenance and analysis of Microbiology data and works with other plant personnel to resolve problems related to actual or potential product quality concerns. The candidate must provide guidance and training to all staff members. YOUR ROLE - Leads and executes protocols (including environmental monitoring studies and equipment/method validations). Performs biological assays of commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process & cleaning validation samples, package samples and components. - Laboratory assays included particulate testing, growth promotion of media, sterility testing, raw material testing, bioburden, membrane filtration, plate reading, endotoxin testing and environmental monitoring. Works in a team environment to support internal and external customer microbiology testing services. - Identifies technical issues, atypical or out-of-specifications test results, instrument malfunctions and methodology problems and leads the investigation process to resolve and correct. Performs studies to support the validation of test methods and ongoing validation studies as needed. Ability to teach and perform gown qualifications for all personnel in the facility. - Implements on-going studies to document the scientific suitability of test methodologies fundamental to conformance and assessment. Ability to carry out method development/validation work with minimal guidance. - Accountable for the accuracy and validity of testing results. Analyzes trends microbiology data on a monthly basis to identify potential concerns with product quality and correct deviant situations. Performs mathematical calculations, interprets results, and records observations. - Ability to keep accurate records and performs monthly trend analysis for microbiology data to identify potential concerns with product quality and correct deviant situations. May utilize Laboratory Information Management Systems. Develops problem solving skills. Compiles data and generates reports in support of investigations, APQRs, KPI's, QMRs, and validations. - Trains all analysts in new and existing procedures, techniques and governmental regulations as directed by Manager. Mentors analysts by providing technical knowledge and support in resolving technical problems and reviewing documents. - Maintains all related records, prepares and records media, buffers and reagents, etc., and maintains work area in a neat and orderly manner. Schedule and coordinate testing activities of the group. Represent the microbiology department on relevant teams (Kaizen, Lean Sigma) to help improve processes throughout the facility. Maintain inventory and reconciliation of laboratory supplies and perform protocol execution. Provide laboratory with an audit ready status as compared to global regulatory agencies as applicable. - Records and reports results and significant observations. Performs special testing and performs instrument and process validations. Responsible for maintaining inventory and reconciliation of laboratory supplies. The Microbiology lead will be responsible for laboratory QA functions including, but not limited to: OOS investigation, exception reporting/investigation, SOP writing/revising, external team participation, validation activities, new product introduction, records review, SOP/SM-R/specification management, and auditing. - Analyzes and interpret project/study/investigation results and findings. Determines next steps under guidance of manger and in compliance with applicable regulations; carries out technical and administrative duties as assigned. Responsible for review and approval QC test results as well as logbooks for accuracy and completeness and conformance to SOPs. Department Specific/Non-Essential Functions: - Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. - Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. - Report all safety and/or environmental incidents to management immediately. - Proactively manage and maintain regulatory compliance (US/EU/WHO/Brazilian/Korean standards). YOUR BACKGROUND - BS in Microbiology, Biology, or in similar life science preferred. - Minimum 6+ years laboratory experience, preferably in the pharmaceutical industry. - Ability to perform: Environmental monitoring of clean rooms and facility water systems, kinetic LAL, gel-clot LAL, filtration testing, particulate matter testing, 14-day sterility testing, and operation of laboratory equipment (Autoclave, Glassware Washer, etc.). - Knowledgeable of aseptic techniques, clean room behaviors, MC Excel, PowerPoint, Access, and investigation writing. - Ability to train personnel on various procedures and demonstrates effective communication with both team members and other plant support groups. Cognitive Requirements: - Good interpersonal and verbal/written communication skills. - Able to use computer for data analysis. - Knowledge of laboratory safety, material safety; working knowledge of cGMPs, GLPs, and FDA requirements. - Self-motivated, energetic, enthusiastic, and team oriented.