Colby Carrasquillo
Levittown
Summary
Quality Assurance and Document Control Coordinator with on job training experience in enhancing product quality through ISO 9001 compliance and CGMP policies. Proficient in Microsoft Excel, Quality Control, and SOP Management, with a strong focus on continuous improvement and internal audits. Demonstrates a commitment to operational consistency and data accuracy, aiming to strengthen organizational quality management frameworks. Demonstrates dedication, ambition and commitment. Already established foundation on site, good rapport with staff, and includes added benefit of beginning from inspector. Project management certified and experience working with project managers.
Overview
10
10
years of professional experience
Work History
Assistant Quality Assurance Manager
CCL Clinical Systems
Garden City
03.2024 - 09.2025
- Developed quality assurance protocols to enhance compliance with industry standards.
- Collaborated with cross-functional teams to resolve quality-related issues effectively.
- Conducted regular audits to ensure adherence to quality management systems.
- Trained staff on best practices for quality control and assurance processes.
- Utilized data analysis tools to monitor product quality and identify trends.
- Implemented corrective actions following quality failure investigations and root cause analyses.
- Ensured that all Quality Assurance personnel were properly trained on current policies, procedures and best practices.
- Investigated customer feedback regarding product defects or discrepancies in service delivery.
- Identified areas where improvements could be made within the Quality Assurance process and worked with relevant stakeholders to implement changes.
Quality Assurance and Document Control Coordinator
CCL Label
Garden City
03.2023 - 03.2024
- Ensure enhancement of product quality.
- Prepare certificates and maintain detailed batch records, ensuring data accuracy.
- Conduct quarterly audits, identifying and resolving discrepancies efficiently.
- Align internal SOPs with industry standards, improving operational consistency.
- Implement comprehensive ISO 9001 compliance protocols while maintaining CGMP standards, strengthening organizational quality management framework.
- Thoroughly review and evaluate batch records for label generation jobs.
- Prepare Certificates of Analysis (C of A) and/or Certificates of Material Compliance (C of MC) and/or Certificates of Conformance (C of C), as well as perform verifications/sign offs of mentioned documents.
- Execute quarterly internal audits to assess various aspects of production and documentation processes (QA, Design, Inspection, Integration, Printing and Project Management).
- Prepare and perform monthly re-test materials list.
- Prepare a monthly list of materials for destruction.
- Maintain meticulous records of: Batch record reviews, Internal discrepancies, Customer complaints, Number of jobs inspected by clinical labeling inspectors, Training records, Calibration (Scales, Rulers and Temp. Stick), Inspection Handbook, Quarantine material, Certifications (Pest control, Calibration, Service agreements, etc.), PMS coated and uncoated color standards, CAPA's and Effectiveness reports.
- Create and issue document change/change control requests when applicable.
- Create and issue process deviation requests when applicable.
- Ensure the Maintenance and distribution of updated documents related to operations.
- Review and determine the disposition of: Controlled documents Quality issues (stock appearance/adhesive functionality), Materials (Incoming and/or Existing).
- Perform reviews and approvals of: Lot sets, Assignment sets, Label copy proofs, BMS IRO proofs.
- Perform periodic audit checks for BMS jobs in the system to ensure correctness of the job status report print outs against total clearances performed.
- Track and report on supplier issues.
- Perform and verify all repacks for blank label stock.
- Provide count verification for all blank label stocks.
- Master Control administrator.
- Knowledge of IMS and JMS systems: Maintain and upkeep all IMS statuses, Document retest and expiration dates for all materials, Initiate the release of all jobs in the JMS system.
- Review and post all track and trend reports as well as KPI (Key Point Indicators) for company viewing.
- Perform and document Area Clearance Verification as required for all areas.
- Communication: Collaborate with production and teams to resolve discrepancies and provide guidance on corrective/preventative actions when necessary.
- As part of continuous improvement, identify opportunities for process optimization and improvements in all processes, contributing to enhanced efficiency and compliance.
- Approvals for all IT updates/changes.
- Perform verification and approval of shipments.
- Assist in preparation and implementation of operational SOPs.
- Performing investigation reports/complaint rejection reports.
- Assist in the overall control of operational procedures.
- Confirm all required documents present with incoming materials.
- Verify all booklet specifications.
- Spearheaded internal SOP alignment initiatives across departments, enhancing operational consistency and regulatory compliance.
- Maintain and support audit readiness.
- Maintain communications regarding quality events with customers, suppliers and internal staff.
- Orchestrated document control processes for certificates, batch records, and compliance documentation, ensuring meticulous accuracy and regulatory adherence.
- Led quarterly internal audits across multiple departments, identifying improvement opportunities and implementing solutions to enhance operational efficiency.
- Developed streamlined processes for managing change controls, deviations, and CAPA documentation, improving organizational response to quality challenges.
Manager
Burger King
Wantagh
08.2017 - 02.2023
- Managed cash flow and ensured accurate bank deposits.
- Resolved customer complaints to improve service quality.
- Coordinated deliveries, ensuring product quality and accuracy.
- Maintained inventory records to optimize stock levels.
- Scheduled staff shifts and improved operational efficiency.
- Streamlined staff scheduling processes and duty assignments, enhancing operational efficiency and improving team productivity during peak hours.
- Executed daily financial reconciliations and banking procedures, maintaining accurate records and ensuring compliance with corporate standards.
- Coordinated with vendors and delivery partners to establish reliable supply chain operations, guaranteeing quality and timely product availability.
- Developed effective resolution strategies for customer concerns, strengthening guest satisfaction and maintaining positive brand reputation.
- Implemented data-driven inventory management protocols, reducing stockouts while optimizing storage capacity and ensuring fresh product availability.
- Analyzed peak hour patterns to restructure staff scheduling, leading to improved coverage and enhanced customer service during high-traffic periods.
- Pioneered new training protocols for conflict resolution, equipping staff with tools to transform customer complaints into opportunities for loyalty building.
- Orchestrated comprehensive daily reconciliation procedures, ensuring financial accuracy and maintaining pristine audit compliance records.
- Optimized staff deployment during peak hours through data-driven scheduling, enhancing service efficiency and reducing customer wait times.
- Implemented strategic inventory control measures combining real-time tracking with demand forecasting to minimize waste while ensuring product availability.
- Executed comprehensive daily financial procedures and reconciliations, maintaining pristine accuracy in cash handling and banking operations.
- Fostered strong vendor relationships and streamlined delivery protocols, ensuring consistent product quality and timely stock replenishment.
Bank Teller
TD Bank
Wantagh
01.2022 - 12.2022
- Processed customer transactions efficiently and accurately.
- Provided exceptional customer service and resolved inquiries promptly.
- Managed cash drawer and balanced daily transactions meticulously.
- Educated customers on banking products and services effectively.
- Utilized banking software to record transactions and update accounts swiftly.
- Collaborated with team members to improve workflow processes regularly.
- Maintained compliance with bank policies and procedures consistently.
Busboy
Riellas
Levittown
02.2016 - 07.2017
- Cleaned tables and replaced linens to ensure a welcoming dining environment.
- Efficiently transported dishes to kitchen, enhancing workflow.
- Managed stock of dining essentials, ensuring uninterrupted service.
- Quickly addressed spills and breakages, maintaining safety and cleanliness.
- Maintained pristine dining environment through systematic table preparation and thorough sanitation protocols, enhancing customer experience and table turnover efficiency.
- Streamlined dishware collection and organization processes, reducing kitchen bottlenecks and enabling smoother service transitions during peak hours.
- Coordinated with servers and kitchen staff to ensure seamless dining operations, contributing to improved service flow and guest satisfaction.
- Monitored and maintained optimal inventory levels of dining supplies, preventing shortages while maximizing operational efficiency.
- Facilitated quick table reset procedures during high-volume periods, supporting continuous service flow and enhanced dining room capacity utilization.
- Executed comprehensive table turnover protocols, reducing reset times and maximizing seating capacity during peak dining hours.
- Implemented systematic cleaning schedules and sanitation procedures, ensuring consistent dining room presentation while meeting health standards.
- Developed optimized dish collection routes, minimizing disruption to dining guests while improving kitchen workflow efficiency.
- Reorganized supply storage systems for improved accessibility, leading to quicker table resets and enhanced service continuity.
- Orchestrated comprehensive table reset protocols during peak hours, reducing turnover time and maximizing seating efficiency while maintaining quality standards.
- Implemented strategic dish collection routes throughout dining areas, minimizing guest disruption while optimizing kitchen workflow and service continuity.
- Synergized with kitchen and service teams to coordinate seamless dining operations, enhancing overall guest experience and operational flow.
Education
Associates degree - Liberal Arts
Nassau Community College
Garden City, NYSkills
- ISO 9001
- CGMP
- Internal Audit
- Quality Control
- SOP Management
- Microsoft Excel
- Microsoft Word
- Quality Assurance
- Quality Management
- Continuous Improvement
- Analysis
- Inventory Management
- Good Clinical Practice
- Lean Six Sigma White Belt
- Project Management Certified
- Quality risk management
- Data integrity and computer system validation certified
References
- Maria Sisa, CCL Clinical Systems, (631) 300-9945
- Hemali Parkha, CCL Clinical Systems, 16312901200
- Gabriel Baquero, Teachers Federal Credit Union, 5164684683
- Christina Rivera, Burger King Vice President, 7184149067
Languages
- English
- Spanish
Timeline
Assistant Quality Assurance Manager
CCL Clinical Systems
03.2024 - 09.2025
Quality Assurance and Document Control Coordinator
CCL Label
03.2023 - 03.2024
Bank Teller
TD Bank
01.2022 - 12.2022
Manager
Burger King
08.2017 - 02.2023
Busboy
Riellas
02.2016 - 07.2017
Associates degree - Liberal Arts
Nassau Community College