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Job Description
- Req#: QUALI003224
- Perform routine QC testing in accordance with SOPs and cGMP guidelines. Limited supervision.
- Perform verification of data to ensure accuracy. Perform review/approval upon discretion of supervisor.
- Utilize a wide range of electronic systems such as ERP, QMS, LIMS, and equipment software. Author and revise SOPs.
- Resolve routine problems by utilizing appropriate resources. Provide problem solving skills to support investigations.
- Participate in protocols for procedural and instrumentation validations/qualifications.
- Assist with audit readiness of laboratory area and calibration and maintenance of laboratory equipment.
- Work on special projects as needed. Contribute towards continuous improvement.
- Considerable knowledge of the job (general and detailed) including practical applications to situations ordinarily encountered. Train on and maintain knowledge of current regulatory requirements and relevant internal procedures.
- Work independently and as a team player with quality and attention to detail. Good communication skills both oral and written. Effectively and efficiently participate in assigned tasks in a quality manner.
- Actively promote safety rules and awareness. Report and take initiative to correct safety & environmental hazards. Work with potentially hazardous chemical materials on a daily basis. Demonstrate good safety practices at all times including the appropriate use of protective equipment.
- Actively demonstrate the Lantheus values of accountability, quality, efficiency, customer service, collaboration, and safety, as well as appropriate workplace behaviors and professionalism, including respect, flexibility, and a positive attitude toward work and others.
- Typically requires 3-5 years of experience with a BS in a related scientific/technical discipline or equivalent combination of education and relevant experience in the pharmaceutical industry, related GMP environment, or equivalent.
- Flexibility with scheduling requirements-may include shifts, overtime, weekends and holiday coverage, including during adverse weather conditions. Some non-routine travel may be required.
- Work with (or in proximity to) potentially hazardous chemical materials and must be able to lift/move materials, e.g. 50 lb. lead/shields, gas cylinders, and chemicals (individual and multiples in cartons).
- Ability to pass visual inspection criteria including color differentiation.
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.
Perform testing on incoming materials, finished products and stability studies in QC Laboratory. Work in both lab and warehouse areas.
Area Specific Requirements
Perform testing and release of components and materials; release and stability testing of API, raw materials, and finished product, visual inspections (qualified operators). QC warehouse incoming material inspections using Acceptable Quality Level (AQL) standards, dock to stock, material status, inventory management. Component and material verifications (functional and dimensional verifications), raw material sampling, cold product and material stability setup/pulls and storage/inventory, reserve (retain) storage and inventory, complaints handling, and project support.
Key Responsibilities/Essential Functions
Basic Qualifications
Other Requirements
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.
About the company
Learn how we develop, manufacture and commercialize precision diagnostics and radiopharmaceuticals to Find, Fight and Follow® disease.
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