QC Physical Testing Analyst

Lantheus Brand•Billerica, MA
•Onsite

About The Position

Lantheus is seeking a strong candidate to perform routine and advanced testing on incoming materials, reference standards, solutions, finished product release and stability in the QC Laboratory following cGMP standards. This is a site-based role requiring an onsite presence 5 days a week in Billerica, MA.

Requirements

  • Associate’s degree and typically 5 years of related experience; or a BS degree and 3 years related experience; or an equivalent combination of education and work experience.
  • Degree in a scientific discipline and experience in the pharmaceutical industry, related GMP environment, or equivalent highly preferred.
  • Must be able to pass pre-placement eye exam for color and have correctable vision.
  • Vision acuity capable of particulate detection required.
  • Must be able to lift/move materials up to 50 lbs, e.g. gas cylinders, chemicals, lead/shields.
  • Able and willing to work with, or in proximity to, potentially hazardous chemical, biological, and/or radioactive materials with proper training.

Nice To Haves

  • Experience having used analytical instrumentation highly preferred.
  • Experience with LabVantage LIMS and SAP preferred.
  • Effective communication skills and good team player dynamics are preferred; understanding of when and ability to escalate issues in a productive manner also highly preferred.

Responsibilities

  • Perform routine QC testing in accordance with SOPs and cGMP guidelines.
  • SME who can troubleshoot, may require assistance. Minimal supervision required.
  • Perform a variety of basic to complex methods utilizing lab equipment such as calipers, rulers, microscope, and Raman Spectrometer and material sampling.
  • 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 ERP, QMS, LIMS, and equipment management software.
  • Author and review SOP changes; participate in change controls, CAPAs, etc.
  • Resolve routine and advanced problems by utilizing appropriate resources.
  • Provide problem solving skills to support & possibly lead investigations.
  • Participate in protocols for procedural validations and instrumentation qualifications.
  • Work on special projects as needed.
  • Contribute towards continuous improvement.
  • Train on and maintain knowledge of current regulatory requirements and relevant internal procedures.
  • Actively promote safety rules and awareness.
  • Demonstrate good safety practices at all times including the appropriate use of protective equipment.
  • Report and takes initiative to correct safety & environmental hazards.
  • Work individually and as a team with quality and attention to detail.
  • Good communication skills both oral and written.
  • Effectively and efficiently participate in assigned tasks in a quality manner.
  • Demonstrate & adhere to Lantheus corporate Values.
  • Actively demonstrate quality, accountability, customer service, efficiency, collaboration, and safety, as well as appropriate workplace behaviors and professionalism, including respect, flexibility, and a positive attitude toward work and others.

Benefits

  • Comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage.
  • Life and disability benefits.
  • Pre-tax accounts.
  • 401(k) with company contribution.
  • Variety of other benefits.
  • Generous time off package including paid vacation, holidays, sick days, and paid parental leave.
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