Quality Control Microbiology Lead

Background

• Works under general supervision of the Lab Manager in a c-GMP regulated manufacturing environment operating under Q7A standards.
• Employees in position at this level will have a considerable degree of independence in conducting a wide range of experiment requiring expertise in the application and adaptation of numerous research techniques and produce desired results

Tasks

• Environmental Monitoring
• Validation for Endotoxin testing
• Document the environmental monitoring program in the high care Packing Room 108 and 109
• Quality Control (QC) Microbiology Lead ensure that products are free of microbial contamination and safe for consumption.
• QC microbiology lead will also train and update technicians on industry standards and regulations.
• Oversee laboratory workers, inspectors and sometimes third parties engaged in quality testing. These professionals create and implement standard operating procedures (SOPs) for production processes. QC microbiology lead may monitor lab technicians who complete quality control testing on raw materials, inputs and products for quality
• Order Supplies as needed
• Maintain documentation
• Anything deemed necessary for betterment of Jost Quality

Specifications

• S. in Biological Science or related field. (Course work may range from mathematics to biochemistry.)
• At least three (3) years' experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is required.
• May require willingness to work evening and weekend hours

Knowledge of:

• Microbiological technique including rapid release methods (Expert Level)
• Qualifying environmental monitoring processes with reference to cell/gene therapy products (Broad Level)
• Experience in the application of microbiological techniques such as air monitoring, water, testing, surface monitoring, genus and species identification of various microbes (Broad Level)
• Basic analytical laboratory equipment
• MS Office software package
• Skill in:
• Working effectively and efficiently on multiple projects
• Effective, disciplined and demonstrated documentation
• Working effectively in a team environment, including collaboration between development and process division

• Ability to:
• Communicate effectively, orally and in writing
• Develop creative solution to problems
• Meet deadlines
• Exercise judgment while being insightful, logical and methodical
• Maintain a proactive and positive attitude
• Shipping & Production

FLSA

• Exempt

Current Openings for Quality Control Microbiology Lead Jobs at Jost Chemical Co.