Summary: Responsible for the testing and/or coordination related to the environmental monitoring program, product analysis, product stability analysis and related testing in the Microbiology Laboratory in compliance with established laboratory procedures, cGMP and any other established internal or external procedure and policies. The incumbent must comply with all Security guidelines, Environmental Health and Safety regulations required by the job function. Responsibilities: 1. Performs laboratory analysis or 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. The analysis are: bacterial endotoxin, sterility test, bioburden / microbial limit, growth promotion, particulate matter to parenteral products, microbial identification, pH test , ,osmolality, ,density, protein concentration and other analysis related to the release of the products being manufactured. In addition do microbial analyses of: manufacturing utilities (i.e. water, clean condensate, compress air, nitrogen, etc.), The tasks are: preparation and sterilization of materials needed for the analysis such as culture media and the depyrogenation / sterilization of glassware. 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. Audit of aseptic techniques and adequate behavior within the controlled manufacturing environment. Documents if necessary inadequate behavior and generates audit corrective actions if required. Audit the controlled areas and utilities physical conditions (house-keeping) and generates audit corrective actions if required. 2. Trains the manufacturing personnel in environmental monitoring sampling and other aseptic processing techniques. 3. Oversees sample collection from production areas if manufacturing operators are responsible to perform the task. 4. Generates Microbiology /Chemistry Laboratory Investigations Reports (MLIR) and assist in the investigation of out of levels, out of limits and out of trends. 5. Understands, interprets and applies compendial testing. 6. 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 and pH meters, UV, density meter ,conduct meter and other microbiology laboratory equipment. 7. Ensures the reliability of the analytical equipment and the integrity of the physical localities through the proper maintenance and housekeeping of the testing areas and contact as necessary the calibration department or equipment maintenance supplier to assure equipment is calibrated and that the necessary preventive maintenance has been performed. 8. Performs necessary preparations of materials, tests in alignment with Technical Services schedules, validation protocols and special testing requests. 9. Generates as required test summary tables. 10. 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. 11. Documents sample related information/sample custody and results in the Laboratory Information Management System (LIMS). 12. Maintains laboratory work areas in clean and organized conditions apply in 6S program tools to organize and improve laboratory work flow and efficiency and sustains the application of the 6S tools in the work area. 13. Originates purchase orders for the materials needed for the laboratory operation and maintains the inventory. Assure that materials stored in the laboratory are within their expiry period. Follows internal inventory system and documents received and discarded material. 14. Maintains a safe work environment and use required safety equipment. 15. Reviews data results for accurateness in alignment with current good documentation practices and internal procedures. 16. Executes test method, process validation and equipment validation test as per corresponding protocols. 17. Reviews documents and generates the necessary red line document and change requests. 18. Assures to be qualified and trained in the applicable procedures required to perform this job duties/responsibilities and; keeps organized personal training qualification record. 19. Supports the Annual Product Review data gathering. 20. Supports the completion of microbiology related CAPA's 21. Uses results of testing performed in the Incoming Materials Area, Analytical and Microbiological laboratories for the disposition of products and / or raw materials. 22. Assures that stability studies performed at the site follow specific protocols and procedures. 23. 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. 23. Ensures an effective process /system for disposition of raw materials, API's, packaging and labeling materials in his functional area. Knowledge/Skill: Bachelor Degree in Biology, Biotechnology, Medical Technology, Microbiology or Industrial Microbiology. One (1) year of working experience in a Microbiology Laboratory of a Pharmaceutical Industry. 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. Communication skills: foster open communication, active listening and good communication skills in English and Spanish (oral and written). 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) Technical Skills: Knowledge in general laboratory instrumentations such as incubators, sterilizers, oven, scales, pH meters, air samplers, microscopes, Biohazards, UV, densitometer, conduct meter and Laminar Flow Hoods Accurate visual inspection is necessary for the recognition of positive microorganism growth 20/20 visual eye accuracy with or without correction and good perception of yellow color Approve with pass the sight screening test established within the Microbiology Standard Operating Procedure (SOP) SDL2017
