QC Microbiology Supervisor - Lenoir, United States - Exela Pharma Sciences

Description

The QC Microbiology Supervisor leads, and monitoring the daily operations, activities, and workflow for the laboratory personnel. Additionally, you will implement testing standards, policies and ensure safety measures are followed. The supervisor will assist laboratory personnel with career development, performance and other areas. You will report to the Manager, Microbiology.

Job Responsibilities

• Provide general oversight, plan, organize, direct, and evaluate daily laboratory tasks.
• Develop the performance/talent of direct reports.
• Schedule, staff, train, and audit multiple activities for responsibilities.
• Ensure completion of all testing, including special projects/protocols and ensure accuracy of laboratory documentation.
• Help with the implementation and interpretation of applicable quality and regulatory requirements (e.g., FDA, GLP, QSR, cGMP, USP, and CDR rules, and guidelines), and ensure compliance with testing SOPs and specifications.
• Participate in proactive functions that impact production, increase efficiency, create cost savings, improve quality, and provide new product support.
• Operate and troubleshoot procedures for lab equipment, and quality and regulatory requirements important to pharmaceutical and combination drug manufacturing labs.
• Help with plant audit ready status efforts for assigned areas and participate in internal and external audits as SME for department and respond to audit observations.
• Lead technical reviews, investigations, and process improvement projects.
• Identify, and oversee changes within quality systems.
• Assure equipment maintenance and calibration, and internal audits are performed.
• Prepare SOPs and specifications. Write memos, reports, protocols, CPAs, and other appropriate documentation for proper functioning of the lab operation.
• Successful completion of all assigned training plans with demonstrated competence.
• This position may be involved with the transportation and handling of hazardous waste; must successfully complete Resource Conservation Recovery Act (RCRA) training within 1 year of hire, and annually thereafter.

Experience Requirements

• Knowledge of basic laboratory functions, test methods, equipment (including analytical equipment, autoclaves, incubators, and environmental monitoring equipment), processes and applicable procedures.
• Knowledge of FDA regulations, application of Good Laboratory Practices, application of Good Manufacturing Practices and application of Good Documentation Practices.
• Knowledge of laboratory safety including standard precautions and hazardous and biohazardous chemical handling.
• Knowledge of change control practices for major equipment, important systems, instrumentation, and computerized systems.
• Knowledge of quality systems including exception management, change control, document control.
• Knowledge of operating and troubleshooting procedures for lab equipment, and quality and regulatory requirements important to pharmaceutical and medical device manufacturing labs.
• Able to write detailed investigation summary memos that meet the requirements of the Quality Organization and the expectations of regulatory agencies.
• Understand how to implement investigation strategies and apply root cause failure analysis.

Education Requirements

Bachelor's degree Master's Degree/Bachelor's degree in Microbiology or related scientific discipline with approximately 5 years' industry in QC - Microbiology experience. Previous leadership roles preferred.

EOE, including disability/vets.