Biotechnology firm in Kankakee, IL is seeking a QC Group Lead

Our client, a world-leader biotechnology based in Kankakee, IL, is searching for a QC Group Lead with a proven track record of leadership and pharmaceutical microbiology testing.

Manages quality control activities to ensure compliance with company standards and GMP regulatory guidelines

• Supervises activities of testing/development of analytical methods/laboratory programs
• Ensures testing and validation of analytical methods and deviation investigations are completed on schedule according to specifications
• Assists laboratory heads with investigations related to lab programs
• Maintains data in LIMS and approves GMP-related quality control systems including departmental standard operating procedures (SOPs)
• Collaborates to support problem solving activities, ensure quality control training and implement corrective actions
• Bachelor degree in a relevant scientific discipline (Biology, Microbiology, Chemistry, etc.); advanced degree a plus
• 5+ years’ experience in microbiological and biological, chemical or biochemical analytics in a pharmaceutical/medicinal GMP environment

Main Responsibilities and Accountabilities:

• Leads a laboratory group (QC Utilities Monitoring) including day-to-day organization and performance management
• Devises development plans and provides guidance for the individuals in the group.
• Responsible for the hiring and on boarding of new hires. Coordinates training and mentoring of analysts.
• Represents the Laboratory on interdepartmental committee/team meetings.
• Ensures policies and procedures are appropriate to maintain compliance.  Review and approve methods and SOP’s.
• Acts as a liaison between manufacturing and lab group ensuring proper communication between the departments.
• Works with the  developmental scientist and analysts to review inquires of result trends

Preferred skills:

• Industrial Pharmaceutical Microbiology laboratory experience
• Previous experience leading and organizing teams
• Working knowledge of cGMPs and compendial methods
• Proficiency in microbiological testing methods including validation and troubleshooting (e.g. testing of water, pure steam, compressed air, and gas)
• Demonstrated experience with pharmaceutical water systems and/or environmental monitoring
• Knowledge of Alternative Rapid Microbiology methods and automation is a plus
• Ability to manage, analyze and trend large data sets

Leadership skills

• Decision making qualities
• Problem solving skills
• Time management abilities

If you or anyone you know of is interested in this position please email your resume to us for immediate consideration