HEMALI PATEL
Manvel,TX
Summary
Detail-oriented, reliable, quality specialist with experience in GMP compliance, GDP practices, and GLP procedures. Proven ability to enhance quality assurance processes and streamline SOP development while nurturing team collaboration. Achieved notable quality improvements through meticulous documentation practices and effective communication, ensuring adherence to regulatory standards and driving operational excellence. Hardworking professional experienced in field and ready for challenging assignments.
Overview
10
10
years of professional experience
Work History
Quality Control Document Specialist III
VGXI
Woodlands, Texas
01.2024 - Current
- Guided new quality control team members through their job functions.
- Developed training materials and conducted ongoing training sessions for new hires and existing employees.
- Reviews documentation such as batch logs and shipments for accuracy, completeness, and adherence to cGMPs.
- Guided change processes and supported successful change management.
- Maintained accurate records of quality reports, statistical reviews, and relevant documentation.
- Monitored and evaluated supplier performance to ensure compliance with quality requirements.
- Maintained knowledge of current industry developments and regulatory requirements for quality assurance purposes.
- Delivered detailed project management control documents for key project oversight.
- Verified accuracy and integrity of supplied data against established standards.
- Collaborated with stakeholders to identify, investigate, and verify complex records and potential risk issues.
- Verified accuracy of product documentation such as labels, instructions, warnings.
- Monitored QA procedures for adherence by employees, notifying personnel of non-compliance issues.
Quality Control Document Specialist II
VGXI
The Woodlands, TX
01.2023 - 01.2024
- Expertise in Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and Standard Operating Procedures (SOPs).
- Set up documents for individual projects based on specifications.
- Responded promptly to customer inquiries regarding status of requested documents.
- Reviews QC data and prepares certificates of analysis for all materials shipped to the customer.
- Generation of change orders and authoring of new SOPs.
- Collect, prepare, and analyze data for corrective action and process improvement.
- Inspected final products and authorized materials for shipment, maintaining high-quality standards.
- Managed and documented quality investigations and process deviations, maintaining adherence to regulatory requirements.
- Generated and reviewed deviations, investigations, and OOS reports to ensure compliance with quality standards.
Quality Control Document Specialist I
VGXI
The Woodlands, Texas
11.2021 - 01.2023
- Reviewed, compiled, and analyzed information to prepare comprehensive reports.
- Scheduled, initiated, and reviewed stability study data to ensure compliance with client requirements.
- Coordinated stability studies, ensuring timely data review and trend generation for client projects.
- Reviewed documents for accuracy, completeness, and compliance with applicable regulations.
- Reviewed and verified project documents for completeness, format and compliance with contract requirements.
- Generated stability trends for clients to provide comprehensive data analysis.
- Ensured accuracy, completeness, and compliance with cGMPs by reviewing batch logs and shipment documentation.
- Completed data capture forms, equipment logbooks or inventory forms to support testing procedures.
Document Control Administrator
OrthoAccel Technologies Inc.
Bellaire, Texas
01.2018 - 12.2018
- Responsible for documenting, editing, reviewing, and generating all SOPs, clinical documentation, and test scripts.
- Ensured that all working copies of documents were stored appropriately, with no unauthorized changes made to the document after validation.
- Maintained a review of manufacturing activities, determined if records were in compliance with SOP and regulatory requirements, and ensured corrective action as needed.
- Assists with or performs ongoing self-inspections to ensure employees correctly perform procedures; identifies deficiencies, and works closely with training staff to correct any issues noted.
- Management and training staff in communicating SOP and regulatory changes to involved staff and ensuring that documentation of training is complete.
Quality Assurance Intern
OrthoAccel Technologies Inc.
Bellaire, Texas
01.2015 - 12.2017
- Maintained up-to-date records, SOPs, clinical documentation, and training records.
- Assists in analyzing tracking and trending data, and determining appropriate actions to improve trends.
- System SOP, and ensure corrections are made as needed.
- Assisting in the continued training for existing employees, and assisting in the management of business operations by maintaining records and files, inventory reports, and ordering supplies.
Education
Credits towards Degree - Bioinformatics
University of St. Thomas
01.2020
Credits towards Associates Degree - Biology
Houston Community College
01.2013
Skills
- Operational Efficiency Enhancement
- Quality Control Expertise
- Process Quality Management
- Strong Interpersonal Skills
- Good Manufacturing Practices
- Regulatory Compliance
- Strong Detail Focus
- Good Documentation Practices
- Root Cause Identification
- Compliance Quality Control
- Quality Assurance Optimization
- Quality assurance reviewing
- GMP Regulatory Adherence
- Efficient Raw Material Management
- Batch Record Management
- Quality Control Inspection
- Efficient Batch Manufacturing
- Quality assurance experience
- Effective SOP Documentation
- GMP and GLP Knowledge
- CGMP regulations
- Quality assurance protocols
References
References available upon request.
Timeline
Quality Control Document Specialist III
VGXI
01.2024 - Current
Quality Control Document Specialist II
VGXI
01.2023 - 01.2024
Quality Control Document Specialist I
VGXI
11.2021 - 01.2023
Document Control Administrator
OrthoAccel Technologies Inc.
01.2018 - 12.2018
Quality Assurance Intern
OrthoAccel Technologies Inc.
01.2015 - 12.2017
Credits towards Degree - Bioinformatics
University of St. Thomas
Credits towards Associates Degree - Biology
Houston Community College
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