QA Specialist

• Sep 2023 - Present

Quality Assurance Specialist II

• Dec 2018 - Sep 2023

• As the leader of the QAOTF program, I am responsible for developing and enhancing the program by creating relevant documentation and establishing a robust structure. • I effectively managed and coordinated all activities related to the QAOTF program, overseeing a team of 20 colleagues. • The QAOTF program involved analyzing OTF observations, generating quality reports, and implementing necessary process changes, CAPAs, or other quality records. • As part of the QAOTF program, I organized and conducted GMP Walkthroughs to ensure and uphold high compliance standards. • I engaged in client interactions with industry-leading companies such as Kyte Pharma, Moderna, and Gilead Sciences to define timelines for batch record review and closure. • I initiated, reviewed, and managed various quality records such as non-conformances )NCsJ, corrective and preventive actions )CAPAsJ, and change requests )CRsJ. • I played a key role in the creation, review, and management of GMP documentation, ensuring adherence to regulatory standards. • I actively participated in the review and implementation of quality systems to continuously enhance processes and procedures. • I effectively coordinated work between teams to streamline operations and improve overall efficiency. • I actively contributed to internal audits and Gemba walks, promoting a culture of quality and continuous improvement. Systems Knowledge: TrackWise, MODA, DMS, SAP, Show less

QA Manager

• Jan 2016 - Dec 2018

• Manage and provide regular feedback to both internal and external staff members. • Conduct quality control on projects commissioned by national and international clients, including prominent brands like IKEA and Amazon. • Ensure strict adherence to company guidelines and policies, aiming to enhance performance and efficiency. • Organize meetings with managers from various departments across the company to discuss quality performance. • De(ne procedures and structures, ensuring that all teams adopt effective approaches for quality control and checks. • Continuously review and improve tools and equipment, collaborating with the company's developers to enhance productivity within the production chain. • CollaboratewithPro4ectManagerstoplanandexecutequalityassuranceforall projects, ensuring timely delivery and meeting client expectations. • Take responsibility for QA sign-off on projects prior to final delivery to clients. • Generate monthly reports analyzing charts and trend lines. • Report to line managers and directors on the situation and develop action plans to address identified issues. • Ensure that the quality control process is cost-effective and aligns with project margins. Show less

QA Officer

• Mar 2014 - Jan 2016

• Effectively manage and provide regular feedback to both internal and external team members. • Perform quality control on projects commissioned by national and international clients, such as renowned brands like IKEA and Amazon. • Coordinate meetings with managers from various departments to discuss and evaluate quality performance. • Take responsibility for approving projects through QA before final delivery to clients. • Collaborate with Project Managers to plan and execute quality assurance for all projects, ensuring on-time delivery and meeting client expectations. • Establish and refine procedures and structures, ensuring all teams adopt effective approaches for quality control and checks. • Continuously assess and enhance tools and equipment, collaborating with the company's developers to improve productivity in the production chain. • Generate monthly reports that analyze charts and trend lines. • Provide reports to line managers and directors, addressing identified issues and developing action plans accordingly. • Enforce strict adherence to company guidelines and policies, with the goal of enhancing performance and efficiency. • Ensure the cost-effectiveness of the quality control process and its alignment with project margins. Show less

Assistant Quality Assurance Officer

• Oct 2011 - Dec 2013

Main duties and responsibilities include: 1. Procuring high-quality ingredients from trusted and certified companies. 2. Ensuring stringent quality standards for all ingredients used in the production of the final product. 3. Verifying and maintaining the precise combination of ingredients to ensure the superior quality of the final product. 4. Conduct rigorous quality checks at every stage of the production chain to uphold the highest standards. 5. Proactively gathering and evaluating valuable client feedback to continually enhance the product's quality. 6. Reporting to the director and providing insightful suggestions for further enhancing product quality. 7. Identifying and swiftly resolving any issues or bottlenecks in the production chain that may impact quality. 8. Facilitating regular meetings involving all levels of the production chain to foster a culture of quality consciousness and collaboration. Show less