Quality Systems Specialist

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

Responsible for investigating Customer Quality Complaints, coordinating Annual Product Quality Reports (APQR), and Metrics Reporting. Other functional responsibilities include authoring and revising Quality System Documentation, trending and evaluating Product Quality and performing Internal Audits of the quality management system.

Key Responsibilities/Essential Functions

* Initiates complaints in our Quality Management System (QMS)

* Performs Product Quality Complaint Investigations and drives closure of associated CAPA(s).

* Collaborates with Technical Support, Engineering, Analytical Laboratories, Manufacturing, Validation, Customer Service and Regulatory Affairs groups to ensure timely complaint investigations and closure.

* Performs routine trending of product complaints and evaluating trends, escalating issues as necessary.

* Evaluates scientific data for trends, drives Investigations, and proposes the need for changes to manufacturing or control procedures.

* Supports writing and approval cycle for Annual Product Quality Reports (APQR). Manages the development of less complex APQRs, collaborating with internal stakeholders.

* Additional tasks to include: Supporting internal audits and external audits, reviewing documents for compliance with regulatory guidelines and applicable standard operating procedures, authoring document changes, and supporting quality metrics initiatives.

* Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety and environmental hazards.

* Actively demonstrates Lantheus values.

* Other duties as assigned.

Basic Qualifications

* Bachelor of Science in a technical discipline or equivalent combination of education and experience.

* Minimum of 3 years of experience in quality and manufacturing in the pharmaceutical, medical device, or biological industries.

* Experienced in investigating Customer Product Quality Complaints, effectively communicating in written form, and collaborating with various internal and external business partners in problem resolution.

* Organized, detail oriented and self-motivated.

* Exposure to Annual Product Quality Reviews preferred.

* Experience with performance of pharmaceutical GMP compliance audits desirable.

* Position is site based with requirement to be on-site 3-4 days per week.

Other Requirements

* Good planning and project management skills.

* Good verbal, written and presentation skills at all levels both internally and externally.

* Ability to communicate effectively at a variety of levels of the organization, as well as coach and mentor members of GxP functions on compliance requirements and topics.

* Must be detail oriented with the ability to multitask and respond to ever changing priorities.

* Ability to work independently and drive on time completion of responsibilities and assigned tasks.

* 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.