Microbiology Department: Performs microbiology analysis and environmental monitoring assuring compliance withregulatory agencies and procedures.Chemistry Department: Performs chemical analysis and assuring process flow and compliance with regulatory agencies andprocedures.Solution Department: Performs the preparation of the manufacturing solutions used for the manufacture of contact lenses.Monomer Department: Performs the preparation of the formulation used for the manufacture of contact lenses.Incoming Department: Perform Incoming Inspection sampling, physical and chemical analysis and approval of componentsand manufacturing materials assuring process flow and compliance with regulatory agencies and procedures.Microbiology Department1. Performs sampling (. water, air, bioburden).2. Performs microbiological analysis & environmental monitoring3. Performs analysis as per protocols as applicable.4. Performs analysis disposition.5. Performs minor troubleshooting and maintenance to laboratory equipment.6. Verifies periodically the expiration date of laboratory reagents, culture media, etc.7. Performs autoclaving to labs supplies and saline solution filters.8. Participates in laboratory investigations.Chemistry Department9. Performs sampling (water, components).10. Performs chemical analysis of components, manufacturing solutions, product, and protocols as applicable.11. Assures components release in the time expected.12. Performs chemical analysis disposition.13. Performs inventory control for laboratory reagents, standards solutions, and supplies.14. Verifies periodically the expiration date of laboratory reagents and standards solutions.15. Executes protocols and engineering studies related to laboratory processes.16. Performs chemical analysis of components and manufacturing materials, manufacturing solutions, watermonitoring and another applicable test as required.17. Use chemical analysis equipment: Gas chromatographer, Liquid chromatographer, Spectrotophometer UV/IR equipment, and another spectroscopy equipment necessary for the operations.18. Performs chemical analysis disposition.19. Performs minor troubleshooting and maintenance to laboratory equipment.20. Generates and execute validation protocols.21. Participates in laboratory investigations.Solution Department22. Prepares manufacturing solutions to assure compliance with procedures and regulations.23. Supports all manufacturing lines providing the solutions as required.24. Performs equipment routine performance verification.25. Keeps laboratory areas clean and organized. Clean equipment used during the mixing process ( tanks).26. Reports usage of raw materials in BPCS.27. Performs a monthly inventory of components.28. Performs inventory of Solutions in production area.29. Supports solution preparation related validation activities.Monomer Department30. Prepares the monomer formulation as per applicable procedures. 31. Supports all manufacturing lines providing the monomer formulation as required. 32. Participates in laboratory investigations. 33. Cleans laboratory glassware and equipment use during the mixing process. 34. Responsible to organize raw materials and segregate products in the freezer accordingly. 35. Reports usage of raw materials in BPCS. 36. Performs inventory of the monomer formulation in production area. 37. Performs periodically inventory of components. 38. Notifies laboratory supplies and equipment inventory needs to perform analysis. 39. Performs simple analysis of monomer mixture (. water content, absorbance, color, viscosity). 40. Coordinate the disposal of any unused materials, contaminated materials, or out of specification product. 41. Performs and reports work in a safe and organized manner 42. Stay current on all job related or function related information and/or training. 43. Performs chemical analysis, monomer mix formulation. 44. Challenges equipment performance verification. 45. Generates NCRs. 46. Notifies laboratories supplies and equipment inventory needs to perform analysis. Incoming Department 47. Performs incoming inspection sampling and purified water sampling. 48. Keeps laboratory areas clean and organized. 49. Generates documentation following good documentation practices associated to the cleaning, PM and equipment verification and monitoring as per applicable procedures. 50. Performs the physical approval of components and manufacturing materials. 51. Performs visual inspection, analytical and chemical analysis test for components. 52. If is necessary, transports non-hazardous components or manufacturing materials and samples from the warehouse to the laboratory. Shared departmental functions: 53. Reviews of documentation. 54. Challenges equipment performance verification. 55. Generates NCR's and Laboratory Investigations. 56. Performs minor troubleshooting, daily verification, calibration, and maintenance to laboratory equipment. 57. Complies with good laboratory practices and QSR, ISO 13485. 58. Complies with safety and environmental regulations. 59. Participates in laboratory investigations. 60. Performs temperature monitoring, as applicable. 61. Cleans laboratory glassware and equipment use during analysis. 62. Notifies laboratory supplies and equipment inventory needs to perform analysis. 63. Trains personnel when necessary. 64. Complies and Maintain 6S (ROLESS) in the laboratories. 65. Supports other areas as required (., special tests for validations) At least Associate Degree in Science (Microbiology, Biology, Biotechnology, Chemistry, Quality Studies) with equivalent experience. Science technical degree in Chemistry or Science Engineering with a minimum of one (1) year of experience. At least two (2) years of experience in quality laboratories related to microbiology, chemistry, or organic synthesis, with laboratory equipment overall knowledge and GLP.
