Senior Quality Assurance 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 someones 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

Lantheus is seeking a Senior Quality Assurance Specialist to provide Quality Assurance expertise for the QA/QC production and technical organizations to ensure the following: compliance to all cGMPs in issues that affect marketed products and/or raw materials APIs excipients or components.

Key Responsibilities/Essential Functions

Collaborate with full range of personnel in manufacturing and technical work teams that support Production to identify root cause of a problem and determine appropriate corrective action for investigations.

Consult cross functionally to correct nonroutine and or complex issues identify trends and determine corrective actions. Make recommendations that meet multiple technical regulatory and business requirements.

Review and approve investigations CAPAs Change Controls and procedures both internally and externally.

Collaboratively resolve unique and/or adverse situations gather and review information from diverse functional areas and make appropriate quality recommendations based on evidence.

Provide quality assurance leadership and expertise in conducting investigations and making recommendations for targeted data and information collection as required for quality events.

Act as quality assurance resource with the FDA and other government agencies during site inspections.

Alert management of critical issues that have significant impact to manufacturing objectives and timelines while providing a range of achievable solutions.

Provide Quality presence and oversight on the manufacturing floor during active manufacturing.

Review of production records for compliance with cGMPS and procedures

Ensures procedures are followed and revised when necessary to maintain compliance

Conduct On the floor observations of various manufacturing and QC activities as needed.

Represent QA in a range of team meetings processes and initiatives.

Actively promote safety rules and awareness. Demonstrate and support good safety practices at all times including the appropriate use of protective equipment. Report and take initiative to correct safety & environmental hazards.

Ability to multitask in a dynamic environment with changing priorities and meet challenging time lines in spite of obstacles

Actively demonstrate the Lantheus values of accountability communication customer commitment entrepreneurial spirit integrity safety and teamwork.

Ability to work effectively and independently in a fast paced environment without appreciable direction

Strong written and verbal communication skills

Act as a backup for day or night shift QA team members covering Genesis manufacturing activities as needed and provide occasional QA support during weekends for manufacturing support.

In case of unplanned absence reports to Manager above to ensure mandatory tasks scheduled for the day are reassigned.

Basic Qualifications

BS/BA degree in a scientific discipline with 5 years of experience in the pharmaceutical or radiopharmaceutical industry or related GMP environment or equivalent.

This position is sitebased and requires a presence onsite five days per week.

This is day shift position; Monday through Friday on site.

Other Requirements

Aseptic fillfinish experience and familiarity with validation of aseptic manufacturing technologies and facilities is desirable

Routinely scheduled work or overtime work required on evenings weekends and or holidays and potentially in adverse weather conditions.

Potential exposure to hazardous chemical radiological and or biological materials. Required to follow all safety procedures and use personal and protective equipment provided.

Ability to travel up to 10 domestically.

Lantheus is committed to equal employment opportunity and nondiscrimination for all employees and qualified applicants without regard to a persons 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 EVerify 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

Required Experience:

Senior IC