Quality Analyst Iv, Qc Microbiology - 2Nd Shift

Purpose

Perform routine and more advanced testing on incoming materials, finished products and stability studies in QC Laboratory. Perform routine environmental monitoring and utilities testing.

Area Specific Requirements

• Perform Environmental Monitoring and utilities monitoring.
• Familiar with aseptic technique
• Perform bioburden, sterility, endotoxin and other routine and more advanced testing.

Key Responsibilities/Essential Functions

• Work on special projects as needed. Lead continuous development and improvement efforts.
• Actively promote safety rules and awareness. Report and take initiative to correct safety & environmental hazards. Work with potentially hazardous chemical, radiological and/or biological materials on a daily basis. Demonstrate good safety practices at all times including the appropriate use of protective equipment.
• Perform verification and approval of data to ensure accuracy.
• Able to perform in-process batch record review and potentially other functions as alternate for QA
• Represent Quality Control in team meetings and projects.
• Assist with audit readiness of laboratory area and calibration and maintenance of laboratory equipment. May assist with ordering.
• Author, review and potentially act as the business owner for SOP changes; participate and lead change controls, CAPAs, investigations, and other quality systems.
• Work independently and as a team player with quality and attention to detail. Good communication skills both oral and written. Effectively and efficiently participate in assigned tasks in a quality manner.
• Utilize a range of electronic systems such as LIMS and document/equipment management software.
• May write and execute protocols for procedural and instrumentation validations.
• Perform routine QC testing in accordance with SOPs and cGMP guidelines. Minimal supervision.
• Resolve routine and advanced problems by utilizing appropriate resources. Provide problem solving skills to lead and/or support investigations.
• Promote and actively demonstrate the Lantheus values of Accountability, Quality, Efficiency, Customer Service, Collaboration, and Safety, as well as appropriate workplace behaviors and professionalism, including respect, flexibility, and a positive attitude toward work and others.
• Train on and maintain extensive knowledge of current regulatory requirements and relevant internal procedures.

Basic Qualifications

• Typically requires 5-8 years with a BS degree in a related scientific discipline (e.g. microbiology) or equivalent combination of education and previous relevant experience in the pharmaceutical industry, related GMP environment, or equivalent.

Other Requirements

• Routinely scheduled work, and/or overtime work required on evenings, weekends, and/or holidays, including during adverse weather conditions. Some non-routine travel may be required.
• Work with (or in proximity to) potentially hazardous chemical, radiological, and or biological materials and must be able to lift/move materials, e.g. 30 lb. portable equipment, 50 lb. lead/shields.