QC Microbiology Lead

What We Are Looking For

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. The Lead will plan, direct and supervise the administrative activities of the QC Micro Lab and evaluate material and product quality by performing various procedures in the Microbiology Laboratory and manufacturing facility.

Your Role

• Leads and executes protocols including environmental monitoring studies and equipment/method validations.
• Performs biological assays of raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process & cleaning validation samples, package samples and components.
• Performs laboratory assays including particulate testing, growth promotion of media, sterility testing, raw material testing, bioburden, membrane filtration, plate reading, endotoxin testing and environmental monitoring.
• Identifies technical issues, atypical or out-of-specification 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.
• Teaches and performs gown qualifications for all personnel in the facility.
• Implements on-going studies to document the scientific suitability of test methodologies.
• Carries out method development/validation work with minimal guidance.
• Accountable for the accuracy and validity of testing results.
• Analyzes trends in microbiology data monthly to identify potential concerns with product quality and correct deviant situations.
• Performs mathematical calculations, interprets results, and records observations.
• Utilizes Laboratory Information Management Systems.
• Compiles data and generates reports in support of investigations, APQRs, KPIs, QMRs, and validations.
• Trains all analysts in new and existing procedures, techniques and governmental regulations.
• Mentors analysts by providing technical knowledge and support in resolving technical problems and reviewing documents.
• Maintains related records, prepares and records media, buffers and reagents, and maintains work area.
• Schedules and coordinates testing activities of the group.
• Represents the microbiology department on relevant teams (Kaizen, Lean Sigma) to help improve processes.
• Maintains inventory and reconciliation of laboratory supplies and performs protocol execution.
• Provides laboratory with an audit ready status as compared to global regulatory agencies.
• Responsible for laboratory QA functions including 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.
• Reviews and approves QC test results as well as logbooks for accuracy and completeness and conformance to SOPs.
• Proactively manages and maintains 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, MS 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.
• 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.