Quality Control Microbiologist I

Under minimal direction from the manager, performs raw material testing, finished product testing, stability testing, water testing, media preparation, growth promotion of media, antibiotic microbial assay testing, microbial identification, method development testing, suitability testing, antimicrobial effectiveness testing, and other microbial testing as needed. Furthermore, auditing of microbial testing including, but not limited to, water testing, growth promotion of media, and environmental monitoring is executed as necessary. Work is completed with an overall quality and efficiency. Writes, updates, and evaluates new test methods and procedures. Attends team meetings and coordinates projects within the laboratory.

Responsibilities

• Routine Microbial Examination Testing (raw materials, finished products, stabilities).

• Routine water testing, media preparation, growth promotion of media, environmental monitoring, and identification of unknown microorganisms.

• Method development testing, suitability testing, antimicrobial effectiveness testing, antibiotic assay testing and other microbial testing as needed.

• Auditing of testing (e.g. water, growth promotion, environmental monitoring).

• Training of analysts / technicians.

• Perform routine testing to support other groups.

• Perform routine testing to support other groups.

• Follows Environmental, Health and Safety policies and procedures. Performs other duties as assigned or as business needs require.

• Able to work overtime, weekends when required.

Education

• B.S. in microbiology, biology or related life science.

Experience

• B.S. with minimum five years related pharmaceutical microbiology experience.

• Advanced degree in scientific field with 3 yrs. related experience.

• Experience in training of other analysts in laboratory techniques preferred.

Specialized/Technical Knowledge

• Working knowledge of aseptic technique, microbial examination methods, antibiotic microbial assay, microbial identification and proficiency in many of these techniques.

• Excellent knowledge of FDA, USP, ICH, cGMP, and cGLP requirements in a pharmaceutical quality control laboratory.

• Excellent computer skills including MS Office and LIMS.

Functional Knowledge

• Excellent organizational skills and attention to detail.

• Excellent at multitasking, handling multiple projects at one time, and changing priorities based on business needs.

• Self-driven and motivated.

• Excellent problem solving skills.

• Excellent interpersonal and communication skills.

• Time management skills.

Physical Requirements

• Lift/move up to 10 lbs. and occasionally 25 lbs.

• Individual may be required to handle hazardous and non-hazardous materials.

• Individual may be required to wear Personal Protective Equipment.

• Not allergic to chemicals or biosubstances found in the laboratory or production facilities.