Quality Control Analyst III, Microbiology - North Billerica, United States - Lantheus Medical Imaging Inc

Description

Job Description

Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

Summary of Role

Perform routine and 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 advanced testing.

Key Responsibilities/Essential Functions

• Perform routine QC testing in accordance with SOPs and cGMP guidelines. Limited supervision required.
• Perform verification of data to ensure accuracy. Perform approval upon discretion of supervisor.
• Assist with audit readiness of laboratory area and calibration and maintenance of laboratory equipment.
• Utilize a range of electronic systems such as LIMS and document/equipment management software.
• Author and review SOP changes; participate in change controls, CAPAs and other quality systems.
• Resolve routine and more advanced problems by utilizing appropriate resources. Provide problem solving skills to support investigations.
• Participate in protocols for procedural and instrumentation validations.
• Work on special projects as needed. Contribute towards continuous improvement.
• Train on and maintain considerable knowledge of current regulatory requirements and relevant internal procedures.
• 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.

Basic Qualifications

• Typically requires 3-5 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.

Core Values:

The ideal candidate will embody Lantheus core values:

• Let people be their best
• Respect one another and act as one
• Learn, adapt, and win
• Know someone's health is in our hands
• Own the solution and make it happen