Monica Galang Email & Phone Number

Waltham, Ma, Us

Pittsburgh, Pennsylvania, Us

Seeking for opportunity to utilize my skills and technical knowledge to gain continued growth and advancement in technological and manufacturing environment with aspirations to expand career in quality. Over 10+ years of cGMP experience in clean room manufacturing as a process technician and more recently a Batch Record coordinator preparing process orders, reviewing batch records and other process related documentations. Detail-oriented and implements focus on quality and efficiency. Committed to professionalism, collaborate effectively with others and have excellent verbal and written communication skills.

Canonsburg, Pennsylvania, Us

 Completes manufacturing operations activities such as but not limited to dispensing, equilibrating, and filling and device assembly operations.  Cleans, maintains, assembles, operates and troubleshoot automated production equipment such as capsule filler machine inside an isolation containment system (ICS) and capsule equilibrator in accordance to SOPs. Perform manual visual inspection on product filled capsules, identifying defects, to ensure that capsules are in conformance to specifications. Performs Product change over activities. Attend to the monitoring system and alerts, respond appropriately. Ensures consistent product quality based on acceptance criteria. Maintains training requirement, timekeeper and email. Qualified as a subject matter expert (SME) in filling operations. Qualified trainer for dispensing, equilibration and filling operations. Perform SAP transactions to ensure bill of materials are accurately reported on the batch process orders. Effectively communicate with QA, engineering and maintenance department when encountering process related issues. Reviews and revises SOPs to ensure procedures are aligned with process and in compliance of cGMP and safety regulations. Participate in shift pass downs and send out email updates. Qualified delegate to perform area approval and line clearance operations.

Basel, Baselstadt, Ch

Novartis San Carlos, CaliforniaManufacturing Process Technician II 11/28/2012 – 09/28/2015Promoted to Manufacturing Process Technician III 09/28/2015 - Present Completes manufacturing operations activities such as but not limited to dispensing, equilibrating, filling and packaging and device assembly operations. Perform Area Approval, Line Clearance and Reconciliation.Accurately records and processes documentation.Ensures consistent product quality based on acceptance criteria.Cleans, maintains, assembles, operates and may troubleshoot automated production equipment according to SOPs.Detail-oriented and implements focus on quality and efficiency.Perform manual visual inspection on product filled capsules, identifying defects, to ensure that capsules are in conformance to specifications.Perform Environmental Monitoring on ICS equipment including gloves, to ensure it is in conformance to specifications.Initiate AQWA deviations using TrackWise program.Ensures compliance with GMP and HSE regulations, Novartis policies, procedures and standards as appropriate for the role.Provide training on routine tasks to other technicians.Revises and updates SOP's to support manufacturing operationsMaintains training requirement, timekeeper and email.Reviews batch records and equipment logbooks ensuring good documentation (GDP) practices are followed.Received a “Quality Hero” award for the month of September, 2014 for exhibiting good quality behaviors “Speaking up for quality” and “Thinking quality always” by reporting quality observations, including documentation and procedure discrepancies which led to prevent future quality issues on the manufacturing floor.

Ingelheim Am Rhein, Rhineland-Palatinate, De

Perform manual visual inspection on product filled vials, identifying defects, to ensure that each vial is in conformance to specifications.Detail-oriented and implements focus on quality and efficiency.Strictly adhere to SOPs, GMPs & cGMPs, Good Documentation Practices and Safety Guidelines.Constantly checked the Learning Management System to ensure all SOPs, trainings & qualifications are completed and in conformance to the current process.Assisted Filling operation (during product & media fill) with packaging of vials into shippers (containers) in the capper suite, in an ISO 7 classified area. Duties also included inspecting, verifying, reconciling, labeling, and preparing materials for the fill process.Worked in a clean room environment, able to perform strict gowning procedures.Participated in 6S in the Finishing & Bulk Packaging areas.Participated as a room facilitator, duties include instruction passdown, organizing daily tasks, prioritizing scheduled tasks to ensure the team work efficiently and able to meet the daily goal.Accurately complete detail-oriented, process-related documentation(i.e.: equipment logbooks, manufacturing procedures/batch records, shift notes)Perform completion & review of documentation on GMP documents (i.e.: Manufacturing Procedure (Batch Record))Ability to train others on tasks per SOP.Perform bulk packaging process which includes packing vials into shippers (container), printing labels, verifying, receiving & reconciling materials, pallet wrapping and palletizing.Adopt and maintain a teamwork attitude to effectively and efficiently manage production needs within the department.Communicate effectively with peers and management to ensure that all process related issues are properly resolved.Communicate quality issues and complete discrepancy documentation as required in a timely manner.Complete assigned department project work.

Thousand Oaks, Ca, Us

Perform manual visual inspection on product filled vials, identifying defects, to ensure that each vial is in conformance to specifications. Detail-oriented and implements focus on quality and efficiency.Strictly adhere to SOPs, GMPs & cGMPs, Good Documentation Practices and Safety Guidelines.Constantly checked the Learning Management System to ensure all SOPs, trainings & qualifications are completed and in conformance to the current process.Assisted Filling operation with packaging of vials into shippers (containers) in the capper suite, in an ISO 7 classified area.Worked in a clean room environment, able to perform strict gowning procedures.Participated in 6S in the Finishing & Bulk Packaging areas.Participated as a room facilitator, duties include instruction passdown, organizing daily tasks, prioritizing scheduled tasks to ensure the team work efficiently and able to meet the daily goal.Accurately complete detail-oriented, process-related documentation (i.e.: equipment logbooks, manufacturing procedures/batch records, shift notes).Perform completion & review of documentation on Manufacturing Procedures (batch records)Ability to train others on tasks per SOP.Perform bulk packaging process which includes packing vials into shippers (container), printing labels, verifying, receiving & reconciling materials, pallet wrapping and palletizing.Adopt and maintain a teamwork attitude to effectively and efficiently manage production needs within the department.Communicate effectively with peers and management to ensure that all process related issues are properly resolved.

South San Francisco, California, Us

Inspect empty vials, liquid or lyophilized filled product with a focus on quality and efficiency.Accurately complete detail-oriented, process-related documentation (i.e.: work-in-process, vial and component inventories and equipment logs).Setup, operate and troubleshoot equipment.Adopt and maintain a teamwork attitude to effectively and efficiently manage production needs within the department.Effectively communicate with peers and management to ensure that all process related issues are properly resolved.Communicate quality issues and complete discrepancy documentation as required in a timely manner.Strictly adhere to all SOPs, current Good Manufacturing Practices (cGMPs), and safety guidelines during the manufacturing process.Support department-wide continuous learning.Complete assigned department project work.Ability to work graveshift. (Shift hours: 9PM – 6AM)

Herndon, Va, Us

Data Center management including monitoring the physical environment, racking, cabling, labeling of all equipment.Preparing space for server installation including shelf installation, IP requests.Configuration and troubleshooting of hardware, storage, backups/recoveryDocumentation of process and procedure.Assist as necessary on projects or scheduling needs.Troubleshoot and upgrade hardware on existing servers (replace hard drives, power supplies and RAM). Monitor electrical, HVAC, and other critical support systems and follow troubleshooting/escalation procedures accordingly.Escalate technical and facilities issues appropriately.Maintain accurate, complete records for system operations, task lists, problems and resolution updates.Adhere to all data center policies and procedures.Attend to the monitoring system and alerts, respond appropriately.Generate daily shift reports, weekly reports and monthly reports.Ability to work night shift (Shift hours: 9PM - 6AM)

Santa Clara, California, Us

Operation of multiple equipment modules, analytical tools/systems. Equipment modules include: Implanter Varian E500, AMAT XR80, Kestrel, E1000.Performing beam tuning on tool errors. Performing set-ups, visual inspections, data analysis and disposition.Possesses ability to multi-task responsibilities. Routinely performs assigned tasks in Fab with minimal supervision.Interfaces with Engineering/Maintenance for issue resolution.Manages workstation to ensure efficient transition to next shift.Manages cycle time at workstation utilizing inventory reports, equipment and specs. Integrates wafer handling, safety and clean room procedures into daily work assignments.Worked in a cleanroom environment able to adhere to strict gowning procedure.Ability to work long hours in the nigh shift. (Shift hours: 5:30PM - 6AM)

Deinstall and reinstall all external components of a large variety of computers.Fill out documents and inventory as needed.Perform proper cable management for all components. Helpdesk and/or Desktop Support assistant; provide technical or non-technical support for clients via face-to-face dialogue and telephone assistance.

Bachelor Of Science, Computer Engineering Technology

Bachelor Of Science - Bs, Computer Engineering Technology/Technician