LISTING: QC Group Lead with Biotechnology firm; Quality Control; Pharma
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
- 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
- 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