Quality Assurance Chemist Resume Samples

Description :

1. Led the validation of cleaning processes, extending equipment runtime from 72 to 144 hours, ensuring sterility and compliance.
2. Provided analytical support for manufacturing changes, enhancing process validation and scale-up efficiency.
3. Conducted comprehensive testing on particle size, bulk density, and content uniformity to ensure product quality.
4. Validated analytical methods in accordance with industry standards, ensuring reliability and accuracy.
5. Assured quality of new drug products through rigorous validation processes and documentation.
6. Collaborated with cross-functional teams to troubleshoot and resolve quality issues, enhancing overall product integrity.
7. Trained junior chemists on quality assurance protocols and best practices, fostering a culture of quality.

Experience

5-7 Years

Level

Executive

Education

BS

Description :

1. Developed and validated analytical test methods to ensure product quality.
2. Calibrated and maintained laboratory instruments for accurate data collection.
3. Performed routine maintenance and troubleshooting of analytical equipment.
4. Utilized GC-FID, HPLC, and ICP for chemical analysis and quality control.
5. Managed inventory of chemicals and standards using SAP for efficient operations.
6. Conducted non-routine analyses to support product development and quality assurance.
7. Collaborated with cross-functional teams to address quality issues and implement solutions.

Experience

2-5 Years

Level

Executive

Education

GED

Description :

1. Verified raw materials, packaging, and test results to ensure compliance with quality standards.
2. Collaborated with production and shipping teams to facilitate timely release of GMP products.
3. Prepared and submitted FDA reports for GMP products, ensuring accuracy and compliance.
4. Conducted inspections of finished goods, analyzing stability results and testing documentation.
5. Coordinated with microbiology and production teams to address quality issues effectively.
6. Managed daily operations of the instrument lab, ensuring optimal performance and maintenance.
7. Developed a comprehensive database for efficient access to eight years of quality data.

Experience

10+ Years

Level

Senior

Education

BSc Chemistry

Description :

1. Ensured quality assurance for all petrochemical products, maintaining compliance with industry standards.
2. Managed laboratory operations, including equipment calibration, supply ordering, and maintaining cleanliness.
3. Conducted monthly sampling and analysis of storage tanks to ensure product integrity.
4. Collaborated with terminal staff to uphold product quality during storage and transportation.
5. Developed reports to identify and flag impurities exceeding acceptable limits.
6. Coordinated the Records Information Management program, ensuring accurate documentation.
7. Oversaw sample retention processes based on client specifications and regulatory requirements.

Experience

2-5 Years

Level

Junior

Education

BSc Chemistry

Description :

1. Supported global development centers in managing risks associated with chemical handling and processing.
2. Developed and implemented chemical handling standards, ensuring compliance with industry regulations.
3. Ensured adherence to customer analytical and microbiological test requirements through effective leadership.
4. Coordinated with third-party laboratories to meet external testing and compliance needs.
5. Acted as a subject matter expert during customer and regulatory inspections, ensuring smooth operations.
6. Provided guidance on internalizing testing operations to enhance efficiency and compliance.
7. Fostered community relations, leading to the creation of a communication video to enhance public engagement.

Experience

2-5 Years

Level

Junior

Education

BSc Chemistry

Description :

1. Trained associates on FDA compliance procedures and laboratory equipment operation, enhancing team efficiency.
2. Utilized root cause analysis tools to identify and resolve quality issues, improving product reliability.
3. Ensured adherence to SOPs, GMP, and HSE regulations, maintaining high-quality standards.
4. Implemented proactive measures to prevent production disruptions, safeguarding operational integrity.
5. Developed inventory monitoring strategies to prevent raw material shortages, optimizing supply chain management.
6. Conducted analytical tests on finished products, ensuring compliance with quality specifications.
7. Collaborated with cross-functional teams to enhance quality assurance processes and documentation.

Experience

2-5 Years

Level

Junior

Education

Bachelor In Chemistry

Description :

1. Developed and validated analytical methods using advanced instrumentation to ensure compliance with quality standards.
2. Maintained laboratory analysis capabilities to meet production schedules and project requirements.
3. Conducted Gauge R&R studies, achieving less than 5% error across all methods using statistical analysis.
4. Implemented 5S methodology to enhance laboratory organization and efficiency.
5. Utilized quality control measures to ensure accuracy and precision of analytical results.
6. Authored detailed SOPs to document analytical methods, ensuring high repeatability and reproducibility.
7. Upgraded laboratory technology by procuring new instruments and validating existing methods.

Experience

5-7 Years

Level

Executive

Education

BSc Chemistry

Description :

1. Utilized analytical techniques like HPLC, NIR, and ICP to ensure compliance with customer specifications.
2. Maintained and calibrated laboratory equipment to ensure optimal performance.
3. Troubleshot process issues, implementing effective solutions to minimize downtime.
4. Trained new staff on quality assurance protocols and analytical methodologies.
5. Conducted laboratory investigations and CAPA plans, identifying deviations per GMP and FDA standards.
6. Collaborated with teams to address quality gaps and enhance operational efficiency.
7. Prepared microbiological media for testing, ensuring compliance with testing standards.

Experience

5-7 Years

Level

Executive

Education

BSc Chemistry

Description :

1. Oversaw quality assurance for a water treatment program serving 30 million facilities, ensuring compliance with safety standards.
2. Calibrated laboratory instrumentation according to established schedules, enhancing testing accuracy.
3. Collaborated with operators to investigate and resolve out-of-specification product issues.
4. Coordinated with sales and R&D to align product specifications with customer requirements.
5. Conducted inventory audits of raw materials and finished products, reconciling discrepancies with accounting.
6. Managed daily testing and quality checks of finished products in the tank farm.
7. Reviewed and updated existing procedures while implementing new quality assurance protocols.

Experience

5-7 Years

Level

Junior

Education

GED

Description :

1. Designed an automated gas analysis system, saving 80 man-hours monthly by optimizing gas analyzers in the lab.
2. Collaborated with European scientists to enhance compliance with global customer requirements.
3. Upgraded QA lab by implementing new GCMS, improving detection of critical impurities and meeting regulatory standards.
4. Invented a foolproof calibrator, reducing defects cost by $500,000 annually across carbon dioxide plants.
5. Authored a QC instruction manual, effectively training plant operators on equipment operation.
6. Conducted in-field repairs on gas chromatographs, saving $24,000 by minimizing downtime.
7. Streamlined lab processes, enhancing overall operational efficiency and compliance.

Experience

5-7 Years

Level

Executive

Education

BSc Chemistry