Documentation Microbiologist

Quality Seymour, Indiana


Description

Job Summary:

This position is primarily responsible for the data review for microbiological testing. This includes the data for raw materials, finished products, environmental monitoring, manufacturing equipment cleaning samples, supplies and media according to current analytical procedures, SOP’s and laboratory guidelines.

Essential Functions:

• Perform accurate and timely data review for microbiological testing according to current analytical procedures, SOP’s and laboratory guidelines.
• Review laboratory equipment calibration and preventative maintenance.
• Assist in maintaining laboratory equipment and facilities
• Assist in the evaluation and improvement of analytical procedures, SOP’s and laboratory guidelines.
• Special projects or other tasks as deemed necessary based on individual’s qualifications, business needs and QC Management’s discretion.

Training or Experience:

• Minimum of two (2) years of pharmaceutical experience preferred.
• Knowledge of cGMP, USP/NF and FDA Guidelines.
• Excellent oral and written communication skills.
• Exceptional attention to detail
• Working knowledge of Microsoft Word and Excel.
• Experience with Laboratory Information Systems.
• Demonstrated ability to work as part of a cross-functional team.

Education:

• Degree in Biology or related field. Relevant experience may be substituted in lieu of degree.

Supervises/Manages:

• None