Quality Sr. Analyst (PET Supplier)

Lantheus is headquartered in Bedford, Massachusetts with offices in 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 letting 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 Senior Quality Analyst to maintain supplier performance metrics, develop trend data of supplier related processes, log and track supplier quality events utilizing the Lantheus Quality System, and conduct audits of external suppliers for Positron Emission Tomography (PET) products.

Key Responsibilities/Essential Functions

Duties and Responsibilities:

• Reviews and approves supplier deviations, change controls, Corrective and Preventive Actions (CAPAs), and Out of Specification (OOS) investigations.
• Monitors supplier quality events utilizing the Lantheus Quality System, as appropriate.
• Partners with Lantheus technical Subject Matter Experts to assess product/system/validation impact.
• Maintains supplier performance metrics and develops trend data of supplier-related processes.
• Communicates data to senior Lantheus management and suppliers, as appropriate.
• Leads investigations and assures follow up and corrective action closure to reduce and eliminate supplier related defects.

• Conduct audits of external suppliers, as needed.

• Leads teams/projects related to supplier complaint investigation, corrective actions, and quality system excellence.
• Recommends and implements improvements to the supplier quality program induced by new regulations, agency guidance documents, industry standards, new technologies, and internal needs.
• Prepares, maintains, and reviews supplier quality procedures to assure compliance with customer and local, state, federal, and international regulations.

• Works closely with cross-functional teams, including senior management levels, to ensure Lantheus maintains high-quality suppliers and provides appropriate supplier feedback.
• Ensures operational, functional, and compliance excellence.

• Maintains supplier performance metrics, develops trend data of supplier related processes.

• Monitors supplier quality events utilizing the Lantheus Quality System.

• Actively demonstrates the Lantheus values of accountability, quality, customer service, efficiency, collaboration and safety.
• Travel expectation: 10-20%.
• This position is site-based and requires a presence on-site three days per week.

Basic Qualifications:

• Bachelor's degree is required in a related medical, science, or engineering discipline.
• 2+ years working in the pharmaceutical industry.
• 2+ years in a Quality role.
• Excellent written and verbal communication skills.
• Exceptional influencing, partnership, and collaboration skills.
• Proficient with Microsoft Office applications, including SharePoint.
• Excellent oral and written skills.
• Teamwork and collaboration skills.
• Strong attention to detail.

Other Requirements (preferred):

• Experience in automating data processes and workflows using tools such as Power BI, SharePoint, Microsoft Access and Excel, and related technologies.
• Experience using an electronic QMS (eQMS).
• Experience performing audits of third-party laboratories.
• Knowledge of US cGMP, ICH requirements, ISO 9001, US regulatory regulations.
• Experienced in Positron Emission Tomography (PET) manufacturing and aseptic manufacturing, including strong technical understanding of aseptic manufacturing processes, equipment and facilities 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.

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