Microbiology Technician

Position Summary:

The Microbiology Technician will ensure the quality and reliability of products through routine and non-routine microbial analyses of raw materials, in-process materials, and finished products according to United States Pharmacopeia USP) requirements. Perform environmental monitoring of equipment, water systems, and workspace. Perform preservative efficacy testing on product formulas. Accurately record and review laboratory data and documentation. Participate in laboratory investigations of OOS or aberrant results. Troubleshoot equipment and method related problems.

Key Responsibilities:

• Perform analyses on samples according to SOP's and U.S. Pharmacopoeias.
• Accurately record and review laboratory data and documentation according to SOP's and cGMP.
• Sampling of microbiological samples for environmental monitoring.
• Sampling and monitoring of water systems and perform pH, conductivity, and microbiological tests on those samples.
• Maintain laboratory supplies, media, and cleanliness.
• Take part in investigations of OOS or aberrant results.
• Prepare and run Challenge Testing/PET.
• Proper handling and disposal of biohazardous laboratory waste.
• Execute system suitability according to USP methods.
• Maintain accurate, up-to-date and concise laboratory notebooks and records.
• Work closely as a team to complete all required tasks in a timely manner.
• Understand and precisely follow Standard Operating Procedures, global methods, local methods and published standard or compendia methods i.e. USP, ISO, ASTM.
• Understand and apply basic laboratory safety instructions, biohazard handling precautions, and disposal of chemical waste according to local environmental regulations.
• Communicate with other departments regarding production, development, and other business goals.
• Manage time and assigned projects effectively.

Required Skills/Abilities:

• Knowledge of laboratory equipment set-up and operation, common laboratory techniques, and safe biohazardous handling.
• Ability to perform pour-plating test method, aseptic technique, media preparation, and other common microbiological testing methods.
• Knowledge of U.S. Pharmacopoeia test organisms and maintenance of live microbiological cultures.
• Technical writing, verbal and interpersonal communication skills
• Ability to prioritize multiple responsibilities and manage deadlines accordingly.
• Communicate effectively with all members of organization and all levels of management.
• Exceptional attention to detail and high level of accuracy & organization.
• Ability to work independently with minimal supervision in a fast-paced environment.
• Ability to adapt quickly to changing policies and procedures.
• Ability to speak, read and write English.
• Proficient knowledge of computers and Microsoft Office.

Required Education and Experience:

• BS degree in Microbiology, Biology, or related field.
• 0-1 year in a Microbiological laboratory setting.

Preferred Education and Experience:

• 1-2 years of experience in a manufacturing and/or Quality Control area.
• Knowledge of ISO 9001:2015, FDA, and other regulatory compliance.
• Proficient knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 210 & 211.
• Knowledge of U.S. Pharmacopoeias.