QC Microbiologist I

PCI Pharma Services•Madison, WI

About The Position

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Summary of Objective: Conducts sampling and testing of production environments, and/or facility clean utilities, as per approved procedures. Performs Lab work and other tasks as assigned by management. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

Requirements

High School Diploma required. BS/BA degree in Microbiology or related scientific field preferred.
3-5 years’ experience in a cGMP environment. Two years of experience may be replaced by Associates/Non- Scientific Bachelor’s degree. Four years of experience may be replaced with BS/BA degree in Microbiology or related scientific field.
Detail oriented
Ability to multi-task
Ability to gown to work in an ISO-5 environment
Ability to work varied hours as required by the production schedule
Required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear
Ability to sit or stand for prolonged periods of time
Must be able to walk and drive between locations
Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves
Must be able to occasionally lift and/or move up to 50 pounds
Must pass eye exam
Comfortable with working/handling of hazardous materials
Follow written instructions. Perform independent troubleshooting of common issues.
Able to work in a highly complex environment with competing demands and priorities

Responsibilities

Perform routine Environmental Monitoring of the classified clean rooms
Monitor classified clean rooms during manufacturing operations, must gown qualify
Sample and test the Water for Injection System, USP Purified Water systems and Clean Steam systems; perform and document plate reads for all environmental and utility testing with minimal supervision
Write and execute protocols/experiments/SOPs under limited supervision
Reviews work of peers and SOP document changes under limited supervision
May assist senior staff in preparation of investigations, reports and execution of complex protocols
Visual inspection of media fill vials and plates
Perform general lab maintenance/housekeeping
Training of staff in routine processes
Other duties as assigned