Coordinates and distributes laboratory tasks. Generates OOL/OOS/OOT and Quality Event Investigations. Generates Change Request related to the Microbiology Laboratory. Prepares Annual Product Review Reports and QC reports. Assures to be trained and maintains organized his/her and, the Laboratory Analysts qualification (in the assigned tasks) program records. Trains other analysts and helps assure the scheduled trainings are performed Supports the maintenance of the Gowning Qualification Program Revises SOPs' and Testing Standard to assure that in compliance with monographs and directives. Prepares the Laboratory Performance Metrics and assure that are posted in the area. Generates Microbiology Test Methods Validation, Discrepancies and Reports. Assists the supervisor in microbiology assays and equipment troubleshooting. Prepares and gives presentations on microbiology related topics. Participates in company initiatives and special projects. Reviews of method validation/ equipment calibration and maintenance of related documentation. Maintains adequate materials and reagents inventory. Assures the sustainability of the 6S Program. Audits the Microbiology Laboratory, the manufacturing and utilities areas. Supports the evaluation of Microbiology related Directives and complete associated CAPA's Evaluates the product test result trends, post then in the laboratory and discuss with the supervisor and manager. Performs laboratory analysis and other related tasks following established procedures and in full compliance with current governmental regulations, official compendia and any other policy / regulation to generate reliable and timely results, to comply with releases due date, reducing cycle time, and providing internal / external customer satisfaction(laboratory analysis include: bacterial endotoxin, sterility test, bioburden / microbial limit, growth promotion, particulate matter to parenteral products, microbial identification and other analysis related to the release of the products being manufactured, microbial analysis of: manufacturing utilities (i.e. water, clean condensate, compress air, nitrogen, etc.) : Prepares and performs the sterilization of materials needed for the analysis such as culture media and the depyrogenation / sterilization of glassware. Performs environmental surveillance of aseptic and oral dosage form manufacturing and packaging facilities which includes viable (air, surface personnel) and non-viable monitoring. Generates environmental trends and graphs of the controlled environments, post then in the manufacturing areas and discuss them with manufacturing personnel. Audits aseptic techniques and adequate behavior within the controlled manufacturing environment. Documents if necessary inadequate behavior and generates audit corrective actions if required. Audits the controlled areas and utilities physical conditions (house-keeping) and generates audit corrective actions if required. Oversees sample collection from production areas if manufacturing operators are responsible to perform the task. Generates Microbiology/Analytical Laboratory Investigations Reports (MLIR) and assist in the investigation of out of levels, out of limits and out of trends. Understands, interprets and applies compendial testing. Operates laboratory equipment (such as air viable monitoring instruments ; non-viable monitoring devices for particulate matter analysis, Vitek, Micro-seq or other similar equipment use for microbial identification; microscopes; Laminar Flow Hoods and Biosafety Cabinets for the handling of biohazardous material; autoclaves; glassware washer; ovens; incubators, refrigerators; freezers; microplate readers; chart recorders, balances, UV, densitometer, conductometer and pH meters and other microbiology laboratory equipment) and ensures the reliability of the analytical equipment and the integrity of the physical localities through the proper maintenance and housekeeping of the testing areas. Contacts as necessary the calibration department or equipment maintenance supplier to assure equipment is calibrated and that the necessary preventive maintenance has been performed. Performs necessary preparations of materials, tests in alignment with Technical Services schedules, validation protocols and special testing requests. Generates as required test summary tables. Maintains accurate records of all work performed and document test results as per Good Documentation Practices. Maintain laboratory logbooks and worksheets as per cGMP requirements. Documents sample related information/sample custody and results in the Laboratory Information Management System (LIMS). Maintains laboratory work areas in clean and organized conditions. Applies 6S program tools to organize and improve laboratory work flow and efficiency. Sustain the application of the 6S tools in the work area. Finds potential exposure to situations that can impact the performance, efficiency and safety, such as accidents, the handling of potentially toxic products, equipment failure, shortage of materials, unnecessary re-tests and any other situation that may affect the accomplishment of established objectives. Originates purchase orders for the materials needed for the laboratory operation and maintains the inventory. Assures that materials that are stored in the laboratory are within their expiry period and follows internal inventory system and documents received and discarded material. Maintains a safe work environment and use required safety equipment. Reviews data results for accurateness in alignment with current good documentation practices and internal procedures. Executes test method, process validation and equipment validation test as per corresponding protocols. Reviews documents and generates the necessary red line document and change requests. Uses results of testing performed in the Incoming Materials Area, Analytical and Microbiological laboratories for the disposition of products and / or raw materials. Assures that stability studies performed at the site follow specific protocols and procedures. Ensures that stability data supports the retest /expiry date and storage conditions of the product and that a system is in place to assure trending of data for any anomalies. Ensures that the functional area has an effective process /system for disposition of raw materials, API's, packaging and labeling materials Requirements: Bachelor degree in Biology, Biotechnology, Medical technology, Microbiology or Industrial Microbiology. Three (3) years of proven experience working in a Microbiology Laboratory of a Pharmaceutical Industry with exposure to administrative tasks such as coordination of laboratory activities; and preparation of laboratory investigations, APR and Trend reports; and revision of SOPs, forms, Testing Standards and Monographs. Knowledge in laboratory aseptic procedures in a pharmaceutical industry. Knowledge of compliance requirements, cGMP, GLP and FDA regulations and the ability to interpret and apply them. In depth knowledge of a variety of analytical techniques (e.g. BET, Particle Count, Microbial Limit, bioburden, Environmental Monitoring, Sterilit Testing). Communication skills: foster open communication, active listening and good communication skills in English and Spanish (oral and written). Able to make presentations in front of a group in English and Spanish. Technical Skills: Knowledge in general laboratory instrumentations such as incubators, sterilizers, oven, scales, pH meters, air samplers, microscopes, UV, densitometer, conductometer, Biohazards and Laminar Flow Hoods. Self starter with strong analytical and self-management skills. Able to act with integrity, adaptability and self-development. Knowledge in PCs (Words, Excel, Power point) Accurate visual inspection for recognition of positive microorganism growth 20/20 visual eye accuracy with or without correction, good perception of yellow color Candidate must approve with Pass the sight screening test established within the Microbiology Standard Operating Procedure (SOP)
