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Analyst II, QC Microbiology

Analyst II, QC Microbiology

Lantheus Medical Imaging IncNorth Billerica, MA, US
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Job 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

We are seeking a strong candidate to :

  • Perform routine testing on incoming materials, solutions, finished product release and stability in QC Laboratory following cGMP. Perform Environmental and Utilities Monitoring.

Area Specific Information

  • Perform a variety of routine microbiology methods such as Environmental / Utility monitoring, Growth Promotion utilizing lab equipment such as portable air analyzers.
  • Key Responsibilities / Essential Functions

  • Perform routine QC testing in accordance with SOPs and cGMP guidelines. Some ability to troubleshoot. Some supervision required.
  • Perform verification of data to ensure accuracy.
  • Assist with audit readiness of laboratory area and calibration and maintenance of routine laboratory equipment.
  • Utilize a range of electronic systems such as ERP, QMS, LIMS, and equipment management software.
  • May author and review SOP changes; may participate in change controls, CAPAs, etc.
  • Resolve routine problems by utilizing appropriate resources. May support investigations.
  • May participate in protocols for procedural validations and instrumentation qualifications.
  • May 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.
  • Basic Qualifications

  • Requires a BS and typically 2 years of related experience; an advanced degree and limited experience; or equivalent combination of education and work experience. Degree in a related scientific discipline (e.g biology) and experience in the pharmaceutical industry, related GMP environment, or equivalent preferred.
  • Site-centric : This position is site-based in N. Billerica, requires flexibility and requires a full time presence on site.
  • Other Requirements

  • Considered essential personnel; flexibility with scheduling 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.
  • Able to pass eye exam for color and have correctable vision. Vision capable of particulate detection preferred.
  • Must be able to lift / move materials up to 50 lbs, e.g. 50 lb. lead / shields.
  • Work with, or in proximity to, potentially hazardous chemical, biological, and / or radioactive materials with proper training.
  • Experience with LabVantage LIMS preferred.
  • 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
  • Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

    Any applicant requiring an accommodation in connection with the hiring process and / or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.

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    Microbiology Analyst • North Billerica, MA, US

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