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QC Analyst IV

2 months ago

North Billerica, United States Lantheus Medical Imaging Inc Full time
Job DescriptionJob 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 and more advanced testing on incoming materials, reference standards, solutions, finished product release and stability in QC Laboratory following cGMP. Work with radioactive materials on a routine basis.

Area Specific Information

  • Perform a variety of basic to more complex analytical methods utilizing lab equipment such as HPLC, GC, AA, FTIR, UV, KF, Polarographic Analyzer, Dose Calibrator, Germanium Detector and Sodium Iodide Detector.
  • Perform wet chemistry testing.
  • Considered essential personnel; 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 radioactive materials on a routine basis.

Key Responsibilities/Essential Functions

  • Perform routine QC testing in accordance with SOPs and cGMP guidelines. Minimal supervision required. SME who can troubleshoot as needed. Non-routine 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 ERP, QMS, LIMS, and equipment management software.
  • Author and review SOP changes; author change controls, CAPAs, and other quality systems.
  • Resolve routine and more advanced problems by utilizing appropriate resources. Provide problem solving skills to lead investigations.
  • May lead protocols for procedural and instrumentation validations.
  • Work on special projects as needed. Expected to contribute towards continuous improvement.
  • Train on and maintain knowledge of current regulatory requirements and relevant internal procedures.
  • Develops professional expertise, applies company policies and procedures to resolve a variety of issues. Determines a course of action based on guidelines and modifies processes and methods as required.
  • Works on problems of moderate scope which are often varied and routine where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Applies learned techniques and contributes to analysis and investigation to solve problems. Normally receives little instruction on day-to-day work, general instructions on new assignments.
  • Builds productive internal/external working relationships to resolve mutual problems by collaborating on procedures or transactions. Focuses on providing standard professional advice and creating initial reports/analyzes for review by experienced team professionals.

Basic Qualifications

Education/Experience qualifications

  • This position is site-based in N. Billerica MA and Requires a BS and typically 8 years of related experience; MS and 6 years; or equivalent combination of education and work experience. Degree in a related scientific discipline (e.g. chemistry, biology) and experience in the pharmaceutical industry, related GMP environment, or equivalent preferred.

Other Requirements

  • Able to pass eye exam for color and have correctable vision.
  • Work with, or in proximity to, potentially hazardous chemical, biological, and radioactive materials with proper training.
  • Must be able to lift/move materials up to 50 lbs, e.g. gas cylinders, chemicals, lead/shields.
  • Vision capable of particulate inspection preferred.
  • Experience with LabVantage LIMS & Waters Empower CDS preferred.

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.