Quality Analyst IV, QC Microbiology – 2nd Shift
Lantheus Medical Imaging
Billerica, Town of, MA
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
- Familiar with aseptic technique
- Perform Environmental Monitoring and utilities monitoring.
- Perform bioburden, sterility, endotoxin and other routine and more advanced testing.
- Perform routine QC testing in accordance with SOPs and cGMP guidelines. Minimal supervision.
- Perform verification and approval of data to ensure accuracy.
- Assist with audit readiness of laboratory area and calibration and maintenance of laboratory equipment. May assist with ordering.
- Utilize a range of electronic systems such as LIMS and document/equipment management software.
- Author, review and potentially act as the business owner for SOP changes; participate and lead change controls, CAPAs, investigations, and other quality systems.
- Resolve routine and advanced problems by utilizing appropriate resources. Provide problem solving skills to lead and/or support investigations.
- May write and execute protocols for procedural and instrumentation validations.
- Work on special projects as needed. Lead continuous development and improvement efforts.
- Represent Quality Control in team meetings and projects.
- Train on and maintain extensive knowledge of current regulatory requirements and relevant internal procedures.
- Able to perform in-process batch record review and potentially other functions as alternate for QA
- 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.
- 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.
- 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.
- 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.
- 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.