Edwin Macharia

Provided transportation services to individuals using ride-sharing applications such as Uber and Lyft. Managed personal schedule and vehicle maintenance to ensure reliable service.

Ensured compliance with site release SOPs and corporate standards during lot issuance, review, and release processes. Led and participated in investigations of non-lot associated deviations, change controls, and environmental excursions.

Responsible for ensuring the safety, efficacy, purity, and quality of manufactured products through compliance with cGMPs and regulations. Supported the review of batch records and maintained Quality Assurance databases.

Reviewed Master Batch Records and SOPs, providing regulatory feedback. Assisted in investigations by gathering information and writing necessary documentation.

Reviewed and created Master Batch Records and supervised their execution during manufacturing. Participated in meetings and investigations, ensuring operational compliance with FDA and company policies.

Conducted quantitative and qualitative analysis of pharmaceutical and nutraceutical products. Followed safety rules and regulations, conducting periodic safety audits.

Synthesized Active Pharmaceutical Ingredients for contracted organizations. Ensured inventory accuracy and demonstrated technical proficiency in applying cGMP standards.

Conducted studies to collect, review, and analyze information for client reports. Reported findings and recommendations for process improvements.

Performed Quality Control checks of products in formulation development. Updated and executed new SOPs, Analytical Methods, and Quality System documents.

Completed a Professional Science Master's degree with a focus on Biotechnology. Concentrated studies specifically in Quality Assurance principles and practices.

Earned a Bachelor of Science degree with a major in Chemistry. Included coursework in Communications as a minor.

Obtained a Bachelor of Science degree in Biotechnology. Minored in both Chemistry and Biology.