Senior Quality Assurance Specialist
7 days ago
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. In 2023, Lantheus had more than $1B in revenues, led by sales of imaging agents for cardiac ultrasound and for prostate cancer.
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
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 non-routine 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 back-up 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 site-based and requires a presence on-site five days per week.
•This is an overnight shift position; Mon, Tues, Weds 6p.m.-6a.m. and Thurs 6 p.m.-10p.m.
Other Requirements
•Aseptic fill-finish 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 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.
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