Laboratory Manager

Specialty chemical manufacturer located northeast of Cleveland, OH is seeking:

Laboratory Manager to be responsible for managing 1-2 QC Technicians Lead daily and long-term Quality Control activities of the Chemical Plant Quality Control Laboratory.

Will provide leadership as well as plan and implement continuous improvement projects for lab instruments, procedures, and processes.

Will facilitate the output of timely and reliable data for the purpose of process control and product release, as well as ensuring adherence to the Quality, cGMP, Food & Pharmaceutical, and Environmental compliance of finished product.

• Supervise lab employees;
  Includes maintaining work schedule, approving weekly timecards, providing necessary training, selecting employees as required. Counsel and Mentor employees and document performance including performance reviews.
• Ensure training, proficiency, and development of laboratory technicians in the areas of raw material, finished product testing, and cGMP programs.
• Monitor, create, and troubleshoot analytical methods to ensure accuracy and to reduce method variability.
• Report and evaluate product and equipment nonconformances working with Quality Assurance in root cause determination and corrective actions.
• Ensure standardization, maintenance, and optimization of QC lab data inputs and outputs including analytical testing schedules for internal and external testing, as well as KPI’s and metrics for success.
• Maintain QC laboratory equipment including calibration program, selection, installation, validation, MSA, Gage R&R, and maintenance schedules.
• Develop and follow procedures for laboratory compliance to ISO 9001, ISO 14001, and cGMP requirements (Food and Pharma).

• Experience in determining root cause analysis and providing corrective action and or preventative action within a set of regulated specifications.
• Trace metal analysis via ICPMS.
• Ability to trouble shoot standard lab equipment (ICPMS, Titrators, etc)
• Experience of working within batch chemical manufacturing environment.
• Essential supervisory skills to foster team environment.
• Solid understanding of Microsoft Office, Statistics, and cGMP, cGLP, ISO, USP-NF, FCC, HACCP, and SAP desired

• BS in Chemistry (Biology or similar science field)10+ years of relevant experience preferred;
  Previous supervisory experience5 years direct analytical laboratory experience; 5 years of laboratory experience in food or pharmaceutical setting preferred
• Knowledge of analytical methods and instrumentation.
• Knowledge of Statistical Process Control techniques.
• Knowledge of SAP or equivalent management program.*