Miguel Quito Email and Phone Number

• Maintain quality system controls to ensure state of compliance and no critical and major market complaints. • Take appropriate steps to reduce wastages and losses in the analysis process and build improved efficiency. • Act as Quality representative on the floor during manufacturing operations and assist Production personnel with troubleshooting. • Perform Aseptic Gowning successfully. • Perform daily compliance walk-throughs in Production and Warehouse. • Perform release of rooms for Manufacturing and Packaging • Assure release of raw materials and components prior to manufacturing • Control and maintain product labels. • Maintenance of reserve sample storage. • Providing Quality Support during Validation, Cleaning Verification, In-Process Sampling, Media Fills, Vial Filling, Lyophilization, Sterilization • Performing Real-Time Batch Record Review • Initiate and aid in the investigating of Incidents and Deviations • Perform Root Cause Analysis using tools such as Fishbone, KT, 5Whys, etc. • Develops applicable Standard Operating Procedures (SOPs) governing Quality Management Systems. • Supports regulatory inspections and audits. • Communicate results from Daily Compliance walkthroughs • As appropriate, use knowledge and experience to solve straightforward problems. • Ensures Operations are compliant with SOPs. • Use independent judgment, as necessary, in developing systems/processes for use within Quality. • Aid in the identification of Process Improvements on a continuous basis. • Aid in the monitoring of Key Performance Indicating (KPIs) for functional area and ensure systems are operating within target

• Reviewed batch records for correct documentation • Inspected Raw Materials, packaging and manufacturing components. • Responsible for actively participating in production activities during product manufacturing and packaging, to include product sampling and inspection, area clearance to confirm process readiness, temperature and humidity monitoring, and non-conforming event support to resolve in-process issues. • Communicate to multiple departments and supervision to provide timely process and issue updates. • Identify and escalate issues or problems to appropriate supervision. • Perform physical inspection of in-process and finished product samples as assigned and according to the production schedule• Collect samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements for either Retain, Stability or Micro. • Performs GMP related verifications including area, equipment and line clearances, cleaning, room inspection, material verification, etc. according to procedures• Collect and appropriately label Packaging retain samples, and submit to the archive storage• Evaluated Batch production records and documented all manufacturing and process development procedures• Revise and dispense appropriate restricted printed material prior packaging as well as well as retrieve and send for destruction printed material that was rejected during the run and situate unused material after communicating with warehouse to keep accountability

Reviewed batch records for correct documentation Supervised the daily activities of the Manufacturing QA Technicians. Inspected Raw Materials, packaging and manufacturing components. Be responsible for actively participating in production activities during product manufacturing and packaging, to include product sampling and inspection, area clearance to confirm process readiness, temperature and humidity monitoring, and non-conforming event support to resolve in-process issues. Communicate to multiple departments and supervision to provide timely process and issue updates. Identify and escalate issues or problems to appropriate supervision. Perform physical inspection of in-process and finished product samples as assigned and according to the production scheduleCollect samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirementsPerforms GMP related verifications including area, equipment and line clearances, cleaning, room inspection, material verification, etc. according to proceduresCollect and appropriately labels Packaging retain samples, and submit to the archive storageEvaluation of Reserve Samples for Customer Complaints and APR Schedule. Evaluated Batch production records and documented all manufacturing and process development procedures

Responsible for floor level support in a quality role for both Liquid and Powder Pharmaceutical manufacturing Operations.• Responsible for verification of sample collection, real time batch record review, log book verification, and guidance for operations with batch documentation.• Able to apply cGMP principles to the overall manufacturing operation as well as perform the proper assessments on goods based on current procedures and processes.• Responsible for performing both in-process sampling and in-process testing on manufacturing goods as well as participate with projects assigned by quality management. • Manage receiving, issuance, and reconciliation of printed materials • Perform AQL’s as required• Review line releases and inspections• Pull and label samples for customer request, testing, retains, validation, and stability• Author internal procedures• Receiving, Process, and Final Inspections• Use of measuring instruments• Ensure product meets requirements per batch specifications• Able to problem solve by using analytical tools (fishbone diagram, 5 why’s, 6M’s, Ishikawa diagram or cause-and-effect diagram)• Special projects and other duties as assigned by quality management

• Maintain schedule efficiency to meet production goals• Follow production schedule and work with warehouse to get orders pulled and staged.• Weigh cosmetic batches and sample raw materials on daily basis to meet schedule requirements.• Communicate objectives to the compounders and report results to production management team• Accurately weigh/sample materials using the metric system• Handling raw materials and understanding safety procedures associated with handling raw materials • Stirring materials per written instructions• Operating large scales small balances, mixers, forklifts and other electrical pallet movers and drum lifters• Make suggestions for solutions to support daily results, improvement in safety, quality, cost and reliability• Understanding of on the job training • Perform room releases for GMP compliance• Complete understanding of deviations, non-conformances, protocols, SOPs • Perform activities according to CFR 21 parts 700/701 Cosmetic General/Cosmetic Labeling• Complete understanding of SOPs and GMP guidelines• Work effectively with diverse departments such as Production, Operators, managers, warehousing, Maintenance, Quality, etc. To understand and meet/exceed their expectations and achieve desired business results• Perform duties at a satisfactory pace

• Responsible for floor level support in a quality role for both Liquid and Powder Pharmaceutical manufacturing Operations.• Responsible for verification of sample collection, real time batch record review, log book verification, and guidance for operations with batch documentation.• Able to apply cGMP principles to the overall manufacturing operation as well as perform the proper assessments on goods based on current procedures and processes.• Responsible for performing both in-process sampling and in-process testing on manufacturing goods as well as participate with projects assigned by quality management. • Manage receiving, issuance, and reconciliation of printed materials • Perform AQL’s as required• Review line releases and inspections• Pull and label samples for customer request, testing, retains, validation, and stability• Author internal procedures• Receiving, Process, and Final Inspections• Use of measuring instruments• Ensure product meets requirements per batch specifications• Able to problem solve by using analytical tools (fishbone diagram, 5 why’s, 6M’s, Ishikawa diagram or cause-and-effect diagram)• Special projects and other duties as assigned by quality management

• Maintain schedule efficiency to meet production goals.• Follow production schedule and work with warehouse to get orders pulled and staged. Verify components.• Ability to communicate objectives to the line and report results to production management team.• Batching / weighing / sampling materials using the metric system.• Handling raw materials and understanding safety procedures associated with handling raw materials.• Mixing chemicals per written instructions.• Operating large scales, small balances, forklift, blenders and processing tanks.• Make suggestions for solutions to support daily results, improvement in safety, quality, cost and reliability.• Ability to comprehend on-the-job-training.• Perform room releases.• Attend daily Operational Reviews.• Ability to understand deviations, non-conformances, protocols, SOPs.• Document activities according to CFR 21 Parts 210 and 211.• Understand and follow SOPs and cGMP guidelines.• Work effectively with a diverse “customer” group (production / Batching, operators, supervisors, managers, warehousing, maintenance, quality, etc.) to understand and meet/exceed their expectations and achieve desired business results.• Special projects and other duties assigned.

Maintain machine efficiency to meet production goals and minimize line down time.Ability to communicate objectives to the line and report results to production management team.Help implement solutions to support daily results improvement in safety, quality, cost and reliability. Drive overall improvements to current systems to enable sustained performance in these areas.Document production activities according to CFR 21 Parts 210 and 211.Understand and follow SOPs and cGMP guidelines.Work effectively with a diverse "customer" group (production line workers, production supervisor, operation manager, maintenance, quality, etc.) to understand and meet/exceed their expectations and achieve desired business results.Maintained necessary level of communications between shifts.Set up and verified the functionality of safety equipment.

Monitored production operations for compliance with specifications and promptly reported defects.Collected samples during production and tested randomly to determine in-process product quality.Routinely checked measuring equipment to resolve testing problems.Recorded defects and coordinated issue resolution with development team and functional leads.Inspected and packaged products meticulously according to manufacturing specifications.Maintained a high standard of workmanship by using only approved data, materials, tools and test equipment.Identified and helped resolve non-conforming product issues.

Use programs such as AS400, SAP, 3270(main frame), Lotus Notes.and others In charged of helping user of accounts to reset passwords and reestablish service.Open tickets when user needs advance technical assistance.Conference and transfer calls between technicians and users of accounts.If a plant has an issue with any system, make sure to notify the right technician in a timely manner.Multi-task with multi-line phones.Ensured superior customer experience by addressing customer concerns, demonstrating empathy and resolving problems on the spot.Directed calls to appropriate individuals and departments.Effectively managed a high-volume of inbound and outbound customer calls. Addressed and resolved customer product complaints empathetically and professionally.