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Quality Assurance Specialist

2 months ago

Billerica, Massachusetts, United States Lantheus Full time

Lantheus, a leader in the medical imaging sector, is dedicated to enhancing patient care through innovative diagnostics and therapeutic solutions. With a commitment to quality and compliance, we are seeking a Quality Assurance Specialist to join our dynamic team.

This role involves providing comprehensive Quality oversight for the aseptic fill/finish manufacturing suite, ensuring that all processes and systems align with industry standards and regulatory requirements.

Key Responsibilities:

  • Deliver technical guidance in the investigation of quality events, ensuring thorough data collection and analysis.
  • Collaborate with cross-functional teams to identify root causes and implement effective corrective and preventative actions.
  • Evaluate unique situations, synthesizing information from various departments to make informed quality recommendations.
  • Review and endorse protocols, validation documents, and standard operating procedures.
  • Approve change controls and actively participate in Change Control Board meetings.
  • Maintain a visible Quality presence on the manufacturing floor to support operational excellence.
  • Represent Quality Assurance in internal meetings and initiatives, advocating for best practices.
  • Notify management of critical issues impacting manufacturing objectives, providing viable solutions.
  • Promote a culture of safety, adhering to all safety protocols and reporting hazards proactively.
  • Embody Lantheus values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety, and teamwork.
Qualifications:
  • Bachelor's degree in a scientific field with a minimum of 2 years of relevant experience in the pharmaceutical or radiopharmaceutical industry.
  • This position requires on-site presence during standard working hours.
Preferred Skills:
  • Experience in aseptic fill-finish processes and validation of manufacturing technologies.
  • Willingness to work flexible hours, including evenings and weekends, as needed to support operations.
  • Familiarity with handling potentially hazardous materials and adherence to safety protocols.
  • Ability to travel domestically up to 10% of the time.
Lantheus is an equal opportunity employer, committed to diversity and inclusion in the workplace. We welcome applicants from all backgrounds and are dedicated to providing reasonable accommodations for individuals with disabilities.