Quality Assurance

1 week ago

Billerica, United States Lantheus Full time
Description

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

Directs and executes Quality Assurance programs to drive compliance and continuous improvement initiatives within the Company, developing and supporting the company‘s Quality Assurance Unit to minimize risks in a regulated pharmaceutical environment. Leads Quality Assurance operations at the Billerica site, ensuring that goals and objectives are met for product quality and in compliance with all applicable regulations. The role provides Quality leadership and support within the organization for key strategic initiatives and directives to improve overall company performance and future growth.

The position is located in Billerica, Massachusetts.

Key Responsibilities/Essential Functions

  • Collaborate with cross functional leaders to identify Quality program requirements. Develop and maintain a comprehensive plan to optimize resources across Quality Assurance functional groups. Evaluate existing process and compliance activities to identify and remediate gaps.
  • Provide technical leadership to the QA/QC and Manufacturing & Supply Chain organizations, and technical support for validation activities, Quality Event investigation and CAPA remediation.
  • Design and implement a successful strategy for QA oversight within internal Manufacturing and ensure resources are allocated to meet strategic quality oversight initiatives.
  • Ensure deviations, CAPA and investigations are well written and comprehensive with through risk analysis assessments and use of root cause analysis tools. Ensure investigations
  • Ensures the release processes for incoming raw materials, intermediates and finished goods to meet supply chain and manufacturing schedules to ensure ongoing continuity of product supply.
  • Ensures the review and approve/reject production batch records and investigating any unexplained discrepancies and makes the final decision with escalation to Quality Management as required to release a product lot into commerce
  • Ensure staff members‘ activities and operations are in alignment with all internal policies and requirements, in compliance with all external regulatory requirements, in a state of inspection readiness, and that they meet business objectives.
  • Assure continuous compliance to all relevant domestic and international cGMP requirements, effective risk management, assuring collaboration between QA and all other related partners.
  • Maintain current, in-depth knowledge of all internal policies, procedures, technology, systems, and processes, and all related external regulatory requirements and guidelines.
  • Act as a change agent and collaborate with other functions in the organization on complex initiatives and challenges. Drive integrated scientific solutions, and synergy throughout work teams.
  • Actively promote safety rules and awareness. Demonstrate good safety practices at all times including the appropriate use of protective equipment. Report and take initiative to correct safety & environmental hazards.

Basic Qualifications

  • Requires a BS/BA degree in a scientific discipline and minimum of 10+ years experience in Quality Assurance in the Pharmaceutical, Biotech and /or Medical Device industry. Radiopharmaceutical experience a plus.
  • Incumbent must have excellent written, verbal and presentation skills. Must be able to interact effectively with all levels of management, both internal and external.
  • Demonstrated proficiency and knowledge of cGMPs, FDA, EMA and ICH regulatory requirements
  • Must be detail oriented with the ability to multitask and respond to changing priorities.
  • Excellent verbal, written and presentation skills at all levels both internally and externally, including regulatory bodies.
  • Strong collaboration skills are essential; incumbent must be able to influence and drive performance within functional team and cross-functionally.

Other Requirements

  • Experienced in SAP S/4HANA ERP application strongly preferred

Core Values

The ideal candidate will embody Lantheus core values:

  • Let people be their best
  • Respect one another and act as one
  • Learn, adapt, and win
  • Know someone‘s health is in our hands
  • 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.

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 .





  • Quality Assurance Specialist

    4 weeks ago

    Billerica, Massachusetts, United States LanceSoft Full time

    Job SummaryAt LanceSoft, we are seeking a highly skilled Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality assurance and process validation, with a proven track record of ensuring the highest standards of quality in a manufacturing environment.Key Responsibilities- Develop and implement quality...

  • Quality Assurance Specialist

    4 weeks ago

    Billerica, Massachusetts, United States TAJ Technologies Inc Full time

    Job Summary:We are seeking a Quality Assurance Specialist to join our team at TAJ Technologies Inc. The ideal candidate will have a strong background in quality assurance and a passion for ensuring the highest standards of product quality.Key Responsibilities:Develop and maintain quality standards and protocols for processing materials into partially...

  • Quality Assurance Specialist

    4 weeks ago

    Billerica, Massachusetts, United States Access Vascular Inc Full time

    Job Title: Quality Assurance SpecialistJob Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at Access Vascular Inc. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and processes.Key Responsibilities:- Collaborate with manufacturing and supply chain teams to ensure...

  • Quality Assurance Associate

    2 days ago

    Billerica, United States FootBridge Company Full time

    Position Title: Quality Assurance Associate Pay Rate: $20/hr. Schedule: 8:00 am – 5:00 pm Location: Billerica, MA Experience Required: 1-2 years Job Description: The Quality Assurance Associate supports the Quality Manager in maintaining the quality management system, ensuring compliance with ISO standards, and meeting applicable regulatory...

  • Quality Assurance Specialist

    4 weeks ago

    Billerica, Massachusetts, United States Lantheus Full time

    Job DescriptionLantheus is a leading company in the medical imaging field, with a strong presence in Bedford, Massachusetts, and offices in New Jersey, Canada, and Sweden.We are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for providing quality oversight activities for the...

  • Senior Quality Assurance Consultant

    4 weeks ago

    Billerica, Massachusetts, United States Actalent Full time

    Job Title: Sr. Quality Assurance ConsultantJob DescriptionAs a Senior Quality Assurance Consultant, you will serve as a Subject Matter Expert on applicable standards and regulations for the organization. Your key responsibilities will include driving inspection readiness and improvement to regulatory inspection processes relating to cGMP, including FDA,...

  • Gmp Quality Assurance Specialist

    4 weeks ago

    Billerica, Massachusetts, United States Randstad Full time

    Job Title: Gmp Quality Assurance SpecialistJob Summary: We are seeking a skilled Gmp Quality Assurance Specialist to join our team. As a Gmp Quality Assurance Specialist, you will be responsible for ensuring the accurate labeling and packaging of life-changing pharmaceuticals.Responsibilities:* Conduct visual inspections to ensure products meet the highest...

  • Quality Assurance Auditor

    1 week ago

    Billerica, United States Parexel International Corporation Full time

    Home Based, USThe Quality Assurance (QA) Auditor II will have experience and knowledge of appropriate GxP compliance and other applicable regulations and laws, Parexel procedures and appropriate Parexel processes, which allows the individual to plan and conduct internal and external audits independently, or with minimal supervision. Provide advice on...

  • Quality Assurance Auditor

    2 weeks ago

    Billerica, United States Parexel International Corporation Full time

    Home Based, USThe Quality Assurance (QA) Auditor II will have experience and knowledge of appropriate GxP compliance and other applicable regulations and laws, Parexel procedures and appropriate Parexel processes, which allows the individual to plan and conduct internal and external audits independently, or with minimal supervision. Provide advice on...

  • Quality Assurance Specialist

    4 weeks ago

    Billerica, Massachusetts, United States Randstad Life Sciences US Full time

    Quality Assurance Specialist needed for aseptic fill/finish manufacturing suite. The ideal candidate will provide Quality oversight activities and technical expertise to ensure compliance with company guidelines and CGMP regulations.Key Responsibilities:Conduct investigations and make recommendations for targeted data and information collection.Collaborate...

  • Quality Assurance Specialist

    4 weeks ago

    Billerica, Massachusetts, United States MassHire Lowell Career Center Full time

    Job Summary:MassHire Lowell Career Center is seeking a Quality Assurance Specialist to join our team. The ideal candidate will have experience in a formalized FDA or ISO Quality Management System and be able to work independently to perform and process first piece inspections and final inspections with proper documentation.Responsibilities: · Assist in...

  • Quality Assurance Specialist

    4 weeks ago

    Billerica, Massachusetts, United States Lantheus Full time

    Lantheus is a leading company in the field of medical imaging, with a strong presence in Bedford, Massachusetts, and offices in New Jersey, Canada, and Sweden. With over 60 years of experience, Lantheus has pioneered the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.The company is an entrepreneurial,...

  • Quality Assurance Specialist

    4 weeks ago

    Billerica, Massachusetts, United States Gabriele & Company Full time

    Gabriele & Company, a leading recruiting firm specializing in manufacturing and supply chain professionals, is working with a dynamic local manufacturer known for producing highly engineered, critical components utilized in Cloud, Industrial, eMobility, and medical device products. Recent growth requires the addition of a Quality Assurance Specialist, for...

  • Quality Assurance Specialist

    4 weeks ago

    Billerica, Massachusetts, United States Quanterix Full time

    At Quanterix, we are seeking a highly motivated Quality Assurance Specialist to join our Accelerator Laboratory in Billerica, MA.The successful candidate will be responsible for quality review of documents for IVD products and compliance with the QMS.This role will support vendor qualification, audits, complaints, and investigations within the Quanterix...

  • Senior Manager, Quality Assurance

    4 weeks ago

    Billerica, Massachusetts, United States Access Vascular Inc Full time

    Job Title: Senior Manager, Quality AssuranceAbout the Role:We are seeking a highly skilled and experienced Senior Manager, Quality Assurance to support our Manufacturing Quality team. This role is critical in ensuring that our products meet the highest standards of quality and compliance.Key Responsibilities:Lead and manage the Manufacturing Quality team to...

  • Quality Assurance Specialist II

    4 weeks ago

    Billerica, Massachusetts, United States Quanterix Full time

    Quality Assurance Specialist II Job DescriptionAbout the Role:We are seeking an experienced Quality Assurance Specialist II to join our team at Quanterix. The successful candidate will be responsible for ensuring the quality and compliance of our products and services.Key Responsibilities:* Establish and maintain a culture of trust and compliance with...

  • Quality Assurance Specialist

    1 week ago

    Billerica, United States Lantheus Full time

    DescriptionLantheus 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...

  • Senior Manager, Quality Assurance

    4 weeks ago

    Billerica, Massachusetts, United States Access Vascular Inc Full time

    We are seeking a highly skilled and experienced Senior Manager, Quality Assurance to support our Manufacturing Quality team. This role is critical in ensuring that our products meet the highest standards of quality and compliance.The ideal candidate will have a strong background in quality management within the medical device industry and a proven track...

  • Senior Quality Assurance Engineer

    4 weeks ago

    Billerica, Massachusetts, United States Motion Recruitment Full time

    Our client is seeking a Senior Quality Assurance Engineer to help foster student growth by offering useful tools to educators through their cloud-based platform.This is a contract to hire, hybrid position with a pay rate of $45 - $55 per hour.The ideal candidate will have approximately 6 years of experience in software testing, with a strong background in...

  • Senior Manager Quality Assurance Lead

    4 weeks ago

    Billerica, Massachusetts, United States Access Vascular Inc Full time

    Job Title: Senior Manager Quality AssuranceJob Summary: We are seeking a highly skilled and experienced Senior Manager, Quality to support our Manufacturing Quality team at Access Vascular Inc.About the Role: This role is critical in ensuring that our products meet the highest standards of quality and compliance. The ideal candidate will have a strong...