Job Description

Carries out the practical work in the laboratory including method development, method validation and trouble shooting. Takes over responsibility for the QC part of projects. Perform required testing on raw materials, intermediates and finished products. Support QC chemist to provide the method technology transfer and project preparation work, make sure the project runs on time and smoothly.

Responsibilities

• Performs, analyzes, and interprets QC and microbial limits testing according to USP and regulatory requirements for raw materials, finished products, and stability samples.
• Perform environmental monitoring which includes water sampling and testing.
• Performs microbiology methods and sampling techniques.
• Performs investigations and completes CAPA in response to laboratory investigations.
• Manages change controls effectively.
• Manages/ supports microbiology projects from production or formulations development dept.
• Actively participates in customer and regulatory audits as area SME.
• Develops and executes validation protocols for test methods and equipment qualification.
• Author and review SOPs and test methods related to microbiology.
• Ensure the microbiological integrity of environment, equipment and facilities.
• Manages product testing based upon internal and customer specifications.
• Managing 3rd party laboratory testing and reporting of data and EM when necessary.
• Report on testing results, including CoA's.
• Maintain equipment, media, and sample logs as needed.
• Ensure the micro lab is adequately supplied and maintained.
• Perform other responsibilities to support the business as requested.
• Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclear.
• Promptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible.
• Stop work where deemed necessary to maintain safety.

Requirements

• 3+ years of lab experience in QC or microbiology.
• Associate's degree or higher in a science-related field.
• Knowledge of USP and regulatory testing standards.
• Good communication and teamwork skills.