Sarah Ombati
Reliable quality controller with extensive manufacturing experience
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About
Reliable quality controller with extensive manufacturing experience. Shares knowledge of Good Manufacturing Practice (GMP) and quality control to create stable products.
Offers Laboratory Management
Systems skills. With strong foundation in scientific principles and laboratory techniques. My background in collaborating with cross-functional teams highlights my communication and teamwork skills. I am adept at managing multiple tasks efficiently, ensuring accuracy and compliance with protocols.
Experienced in isolating and identifying microorganisms in clinical samples, contributing to research and development of antimicrobial treatments. Skilled in utilizing advanced laboratory techniques, DNA extraction, basic molecular techniques, maintaining stringent safety protocols, and collaborating with multidisciplinary teams to achieve research goals. Committed to advancing scientific knowledge and ensuring high standards in laboratory practices.
Dedicated individual with experience in achieving tangible results and cross-team collaboration. Proactive and excited to partner with like-minded individuals to achieve goals.
Experience
Quality control lead - BIOPHARMA LIMITED - Kenya
(2025-06)
- In charge of all activities in the quality control department including assigning analysts work.
- Training and qualification of all the quality control analysts for both microbiology and chemical testing
- Ensure calibration of all the quality control equipment
- Ensure implementation of the standard operating procedures
- Lead investigations of out of specification, deviations and CAPA
- Reviewing batch manufacturing records and approving the certificate of analysis
- Approving raw materials for use in production
- Approving the standard operating procedures and test procedures for raw materials, intermediate, finished and packaging materials
- Approving art works for packaging materials
- Generating monthly report for quality control department
- Interviewing analysts
- Ensure successful product validation
- Verification and validation of methods of analysis
- Ensure installation, verification and qualification of new quality control equipment
- Training of shop floors personnel on the importance of quality.
- Training and ensuring good laboratory practices.
Quality Control/Quality Assurance Microbiologist - BBRAUN PHARMACEUTICAL EPZ LTD KENYA - Kenya
(2020-02 - 2024-04)
- Ensuring personnel follow laid out procedures for various processes
- Lead in developing CAPA mechanisms during microbiological investigations
- Bioburden and sterility testing of raw materials and finished products
- Bacterial endotoxin test in raw materials, water and finished products
- Isolation and identification of cultures
- Disinfectant evaluation and monitoring on their performance
- Environmental monitoring
- Receipt and Sampling of products, packaging and raw materials
- Media preparation and maintenance of reference microorganisms
- Risk analysis for out of specifications and out of trend results
- Evaluation, validation and qualification of processes and equipment
- Lead auditor during internal audit
- Training of personnel on basic microbiology and personnel hygiene
- Authoring and revising various SOPs
- Ascertaining sterility of the process flow through media fills
- Advising the company on various processes.
Quality Control/Quality Assurance Microbiologist - BBRAUN PHARMACEUTICAL EPZ LTD KENYA - Kenya
(2020-02 - 2024-04)
ACHIEVEMENTS
- Successfully implemented plans to achieve a sterile environment in small volume production line.
- Successfully implemented a better documentation process.
- Successfully trained staff on hygiene that is necessary for sterile manufacturing
Microbiologist Trainee - Kenya Plant Health Inspectorate (KEPHIS) - Kenya
(2020-01 - 2020-02)
- Conducted microbiological analysis of fresh foods, nuts, fish, and cereals.
- Analyzed mycotoxins in cereals and groundnuts.
- Performed environmental monitoring.
- DNA extraction of phytopathogens
- PCR machine operation
- DNA sequencing
- Prepared media for laboratory use.
Quality Control Supervisor - Medivet Products Limited (Pharmaceuticals Manufacturer) - Kenya
(2015-10 - 2019-12)
- Sampled raw materials, packaging materials, intermediate products, and finished products.
- Conducted quality control tests on collected samples following standard procedures.
- Prepared and standardized laboratory reagents as per SOPs.
- Executed physical and chemical tests on raw materials, intermediates, finished products, and water against laid-down methods.
- Calibrated various equipment and machines, including balances, pH and conductivity meters, tablet dissolution apparatus, U.V-Visible spectrophotometers, and HPLC.
- Carried out stability tests on finished products.
- Validated analytical and manufacturing methods.
- Participated in internal laboratory audits to ensure compliance with GLPs and GMPs.
- Conducted microbiological analysis, monitored and tested hygiene levels, cultured samples, and analyzed.
- Prepared media and maintained microbiology records.
- Authored and revised various test method SOPs.
Microbiologist Trainee - Lancet Kenya Microbiology Lab - Kenya
(2014-05 - 2015-03)
- Diagnosed bacterial and fungal infections through cultures.
- Maintained QC cultures and rapid tests.
- Conducted phlebotomy duties and microscopy.
- Performed ZN staining and other stains, culture, identification, and sensitivity procedures.
- Conducted parasitology and ran QC tests.
- Utilized microscopy techniques.
- Conducted urinalysis and water testing methods.
Research Officer (Attache) - Coffee Research Foundation - Kenya
(2012-09 - 2012-12)
- Prepared tissue culture media.
- Carried out tissue culture procedures on crops under research.
- Checked for culture contamination and transferred seedlings to the greenhouse.
- Identified bacterial and fungal infections in coffee.
- Screened for candidate pesticides, reared pests, and parasitoids in laboratory field trials for pesticides and integrated pesticide control methods.
Education
Master of Science - Medical Microbiology - Kenyatta University (2019-09)
Bachelor of Science - Microbiology - Kenyatta University (2011-05 - 2015-12)
