Senior Quality Assurance Engineer
Lantheus Medical Imaging, Inc. - North Billerica, MA

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Lantheus Medical Imaging is a global leader in developing, manufacturing and distributing innovative diagnostic imaging agents. For more than 55 years, Lantheus has been dedicated to creating and providing pioneering medical imaging solutions to improve the treatment of human disease. The company’s proven success in discovering, developing and commercializing innovative medical imaging agents provides a strong platform from which to bring forward new breakthrough tools for the diagnosis and management of disease.

Lantheus imaging products include DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension, the leading ultrasound contrast agent used in ultrasound exams of the heart, also known as echocardiographic exams; ABLAVAR® (gadofosveset trisodium), a first-in-class magnetic resonance agent indicated for the evaluation of aortoiliac occlusive disease in adults with known or suspected peripheral vascular disease; Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), a cardiac imaging agent that is the most successful radiopharmaceutical ever introduced and; TechneLite® (Technetium Tc99m Generator).

Lantheus has approximately 600 employees worldwide with headquarters in North Billerica, Massachusetts, and offices in Puerto Rico, Canada and Australia.

In this role the ideal candidate will provide engineering expertise to the QA/QC, production and technical organizations to ensure the following: compliance to all cGMPs in issues that affect marketed products and/or their raw materials, APIs, excipients or components. Responsibilities include:

  • Collaborate with full range of personnel in manufacturing and technical work teams that support Production to identify root cause of a problem and determine appropriate corrective action for investigations.
  • Consult with a range of internal and external clients and collateral contacts to correct non-routine and, or comprehensive issues, identify trends and determine corrective actions. Make recommendations that meet multiple technical, regulatory and business requirements.
  • Review and approve protocols, validation documents, investigations and procedures.
  • Resolve unique and/or adverse situations, gather and review information from diverse functional areas, and make appropriate quality recommendations based on evidence.
  • Provide engineering leadership and technical expertise in conducting investigations and making recommendations for targeted data and information collection as required for quality events. Contributes to data and information collection.
  • Act as engineering technical resource with the FDA and other government agencies during site inspections.
  • Alert management of critical issues that have significant impact to manufacturing objectives and timelines, while providing a range of achievable solutions.
  • Approve change controls and act as chairperson for Change Control Board meetings.
  • Conduct Pre-op GMP checks.
  • Represent QA in a range of team meetings, processes and initiatives.
The incumbent will actively promote safety rules and awareness, will demonstrate good safety practices at all times, and take initiative to correct safety hazards. Additionally, the incumbent will actively demonstrate and promote the Lantheus values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.

Requirements include:
  • BS/BA degree in a scientific discipline with 5 years of progressive experience in the pharmaceutical or radiopharmaceutical industry or related GMP environment, or equivalent.
  • Routinely scheduled work, and or overtime work required on evenings, weekends, and or holidays and, even in adverse weather conditions.
  • Handling of and/or exposure to potentially hazardous chemical, radiological and or biological materials. Required to follow all safety procedures, and use personal and protective equipment provided.