Quality Control Supervisor

• Title: Quality Control Supervisor
• Location: Brooksville, FL
• Industry: Pharmaceutical
• Salary: Based on Experience
• Employment Type: Direct Placement
• Status: Full Time Employee

• Evaluate and implement new analytical technologies, computer systems, software, HPLC and GC data systems, instrumentation, and updated compendia methodologies
• Coordinate scheduling and assigning weekly tasks for departmental personnel, including stability program.
• Review data sheets and direct report laboratory notebooks for accuracy and compliance to microbiological methods.
• Supervise and assist in the use of analytical equipment and techniques for testing.
• Provide technical leadership in analyzing and microbiological techniques.
• Oversee the performance of product testing for release and stability; Author qualification reports and technical methods summarizing test results. Ensure testing and associated documentation is performed and reviewed in a timely manner with high accuracy and reliability.
• Ensure direct reports meet schedules in a high quality and professional manner and ensure work areas conform to cGMP regulations, Standard Operating Procedures and Corporate Policies.
• Revise and review standard operating procedures (SOPs) for laboratory; revisions may be related to procedural improvements, customer requests and/or audit observations.
• Oversee and participate in OOS investigations and departmental quality events as they occur.
• Ensure the inventory and tracking records of supplies and equipment is accurate.
• Actively examine and research current work practices to propose process improvements and increase efficiencies.
• Interact with other departments, including quality assurance and production, to ensure a smooth overall workflow.
• Set annual goals with supervisor to improve job and individual skills and abilities; Maintain a high level of quality of product and improved established efficiency and yield standards.
• All other duties as assigned by management.

• Bachelor s degree in Chemistry, Biochemistry, Microbiology.
• Minimum of 5 years experience in an Analytical or Microbiology QC role supporting a pharmaceutical manufacturing operation.
• Minimum of 1 year supervision experience

• Lift up to 35 lbs.
• Ability to work standing in a laboratory for an 8-hour shift

• Must successfully complete all departmental training modules and meet the requirements as part of ongoing training

• Knowledge of current USP standards
• Knowledge of microbiological and analytical laboratory techniques
• Knowledge of sterile technique
• Experience with microbiological and analytical instrumentation
• Knowledge of FDA/USP guidelines
• Excellent verbal and written communication skills
• Analytical reasoning, root cause analysis and problem solving
• Technical writing: write, read, understand, and interpret technical writing and instructions
• MS Office skills; particularly Word and Excel
• Math and calculation skills
• Multitask and coordinate with operations and quality assurance simultaneously
• Work with a wide range of people to solve problems and resolve issues
• Work in a fast-paced environment
• Ability to maintain flexible task schedule and workflow
• Highly detail oriented with good record keeping skills
• Excellent people skills, with experience collaborating in a multi-disciplinary, diverse, and dynamic team

ADA/EOE

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