Ming Gong
Lincoln,NE
Summary
Experienced Validation Engineer with expertise in cleaning validation, analytical chemistry, and regulatory compliance in pharmaceutical and consumer health industries. Skilled in developing validation protocols, conducting risk assessments, and maintaining validated processes.
Proven ability to collaborate across teams, address regulatory inquiries, and drive quality improvements through data analysis and root cause investigations. Holds a Master of Science in Chemistry and has published research in scientific journals.
Overview
7
7
years of professional experience
Work History
Validation Engineer
Haleon
01.2023 - Current
- Serve as the primary point of contact for cleaning validation processes, ensuring continuous knowledge sharing across teams and global operations.
- Collaborate with Technical teams, QA, QC, Engineering, and Operations to establish and maintain proper cleaning controls.
- Oversee continued cleaning process verification (CCPV), leveraging data trends to ensure processes remain in a validated state of control and proactively identify risks.
- Lead the development and execution of cleaning validation protocols, authoring comprehensive reports.
- Conduct risk assessments for new products, processes, and materials, ensuring appropriate validation and compliance (including MACO calculations and cleaning method assessments).
- Ensure accuracy and completeness of cleaning validation data in accordance with SOPs.
- Provide support during compliance inspections and regulatory agency queries.
- Address cleaning deviations and Root Cause Analyses (RCAs) across multiple value streams.
- Participate in and contribute to site-wide quality initiatives, ensuring adherence to quality standards.
Analytical Chemist
Haleon
01.2022 - 01.2023
- Developed analytical methods and performed cGMP testing to quantify trace levels of nitrosamine compounds in consumer health products.
- Ensured compliance with GMP standards in all testing, documentation, and quality/compliance activities.
- Provided technical support for analytical testing and test development.
- Actively maintained a safe working environment, addressing potential safety concerns proactively.
Quality Assurance Supervisor
Marianna Beauty
01.2021 - 01.2022
- Managed QA tasks including documentation, audits, training, and compliance activities to support the Quality System infrastructure.
- Reviewed and updated SOPs, policies, and training materials to align with regulatory requirements.
- Led a team, evaluated performance, and ensured appropriate staffing and training to support quality functions.
- Facilitated regulatory and safety training for new employees and maintained training records.
- Oversaw customer complaints, vendor complaints, and change controls, driving resolution through corrective and preventive actions (CAPA).
- Supported manufacturing failure investigations and interdepartmental projects involving data collection and research.
- Reviewed and approved production records, stability reports, and inspection reports.
Senior Chemist
LI-COR
01.2018 - 01.2021
- Developed and validated instrumental methods for product analysis, utilizing techniques such as UHPLC-MS, GC, FT-IR, NMR, and UV-Vis spectroscopy.
- Assisted in the development of analytical test methods for research, GLP, cGMP, and clinical studies.
- Conducted stability testing and quality control assessments for raw materials, in-process products, and final products.
- Wrote and reviewed SOPs, validation protocols, and qualification protocols for analytical activities.
- Collaborated with customers to provide technical support and results for ongoing projects.
- Implemented process improvements and contributed to new product specifications and evaluations.
- Trained and supported quality control teams on analytical testing methodologies.
Education
Master of Science - Chemistry
California State University
01.2014
Bachelor of Science - Chemistry
Liaoning Petrochemical University
01.2010
Skills
- Regulatory guidelines
- Risk assessment
- Cleaning validation
- Cleaning protocol
- Cleaning validation reports
- FDA regulations
- Measurements and analysis
- Equipment calibration
- GMP compliance
- Analytical thinking
Publications
Yi, X., Zhang, Y., Gong, M., Zhang, J., Zhou, F., Ca²⁺-Bridges Glu-22 of Aβ(1−42) to Phospholipids and Accelerates the Aβ(1−42) Aggregation Below the Critical Micelle Concentration., Biochemistry, 2015, 54, 6323-6332
Languages
Chinese (Mandarin)
Native or Bilingual
Timeline
Validation Engineer
Haleon
01.2023 - Current
Analytical Chemist
Haleon
01.2022 - 01.2023
Quality Assurance Supervisor
Marianna Beauty
01.2021 - 01.2022
Senior Chemist
LI-COR
01.2018 - 01.2021
Bachelor of Science - Chemistry
Liaoning Petrochemical University
Master of Science - Chemistry
California State University
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