Quality Assurance GMP Intern

1 week ago

Basking Ridge, New Jersey, United States Daiichi Sankyo Full time
Join a Legacy of Innovation 110 Years and Counting

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary

The GMP Quality Assurance Internship is a program that provides training for the intern in the field of pharmaceutical Quality Assurance focused on the activities related to the overseeing of manufacturing and distribution activities of commercial and investigational medicine products. Interns will be provided with work responsibilities like that of an entry-level professional and will allow them to dive into different functions of GMP QA Department such as Audit, Quality Management System, Pharma Product, External Supplier Management and Strategical Operations interacting with key stakeholders of QA departments ensuring a holistic approach of a Pharmaceutical organization. The work responsibilities will build upon classroom studies and give a real-world experience into the regulated environment.

We are currently seeking a GMP Quality Assurance Intern for the year starting in June 2024. This full-time position works for approximately 37.5 hours per week with flexibility to go part time (20 hours per week) during the fall and spring semester. They will be accountable for:

Defining, measuring, analyzing, and improving identified processes within the quality organizationPerforming data analysis for established metrics and identifying potential new metricsSupporting continuous improvement projects assigned potentially within regulatory compliance, internal/supplier auditing, or customer focus activitiesPerforming the necessary daily responsibilities in accordance with current Standard Operating Procedures (SOPs) and GMP regulationsSupport Quality personnel with pharmaceutical investigations to determine root cause and corrective actions.Support inspection readiness activities, including revision, drafts, collaboration for local SOP's and SOI's.Support Quality personnel as part of audit activities of manufacturing, facility, and quality controls areas and operations.Review and compile data for migration into electronic management system and archive.Generate reports, store completed work in designated locations and perform backup operations.Scan documents and print files, when needed.Respond to queries for information and access relevant files.Research and obtain further information for incomplete documents.Comply with data integrity and security policies.Maintaining open and effective communication with all other Quality Assurance team membersOther duties as assigned
Education/ExperienceQualified candidates must currently be enrolled in an accredited undergraduate program with a concentration in life sciences such as Biology, Chemistry, Pharmacy, Biotechnology, or related field. Prior experience in a corporate business environment is preferred; experience in the pharmaceutical industry is a plus. Excellent writing skills and strong computer skills with moderate to advanced proficiency in database and/or spreadsheets.Good organization, documentation, prioritization, and scheduling skills together with an ability to stay focused on assigned tasks and an overall desire to learn.Attention to detail and confidentiality.Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

  • Senior Director, Head of PV Quality

    4 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence...

  • Senior Director, Head of PV Quality

    3 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence...

  • Manager, Global Pharmacovigilance Quality

    4 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence...

  • Manager, Global Pharmacovigilance Quality

    3 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence...

  • Manager, Validation Lead

    3 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence...

  • Associate, R&D Procurement

    17 hours ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence...

  • Test Lead

    3 weeks ago

    Basking Ridge, New Jersey, United States Cognizant Full time

    Cognizant Technology Solutions is looking for "Test Lead" to join in our team of IT professionals in a permanent role. If you meet our background requirements and skills and are looking for an opportunity with these skills and expertise, here is the ideal opportunity for you About Cognizant's QEA Practice:We are the largest Quality Assurance Practice...

  • Test Analyst

    4 weeks ago

    Basking Ridge, New Jersey, United States Cognizant Full time

    Cognizant Technology Solutions is looking for "Test Analyst" to join in our team of IT professionals in a permanent role. If you meet our background requirements and skills and are looking for an opportunity with these skills and expertise, here is the ideal opportunity for you About Cognizant's QEA Practice:We are the largest Quality Assurance Practice...

  • Test Lead

    1 month ago

    Basking Ridge, New Jersey, United States Cognizant Full time

    Cognizant Technology Solutions is looking for "Test Lead" to join in our team of IT professionals in a permanent role. If you meet our background requirements and skills and are looking for an opportunity with these skills and expertise, here is the ideal opportunity for you About Cognizant's QEA Practice:We are the largest Quality Assurance Practice...

  • Test Analyst

    3 weeks ago

    Basking Ridge, New Jersey, United States Cognizant Full time

    Cognizant Technology Solutions is looking for "Test Analyst" to join in our team of IT professionals in a permanent role. If you meet our background requirements and skills and are looking for an opportunity with these skills and expertise, here is the ideal opportunity for you About Cognizant's QEA Practice:We are the largest Quality Assurance Practice...

  • Manager, Management

    4 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence...

  • Manager, Management

    3 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence...

  • Adobe Workfront Trainer

    6 days ago

    Basking Ridge, New Jersey, United States Aditi Consulting Full time

    Note: This is 100% Remote job Please read the information in this job post thoroughly to understand exactly what is expected of potential candidates. Summary:We are looking for a talented Marketing Consultant to join our team to enhance and project manage the training materials and communication for Adobe Workfront. Your expertise will help redefine the...

  • Marketing Consultant Professional

    7 days ago

    Basking Ridge, New Jersey, United States eTeam Full time

    Title: Marketing ConsultantLocation: RemoteDuration: 6+ MonthsResponsibilities:We are looking for a talented Marketing Consultant to join our team to enhance and project manage the training materials and communication for Adobe Workfront. Your expertise will help redefine the usability and interface of the Workfront platform, ensuring different teams within...

  • Marketing Consultant Professional

    7 days ago

    Basking Ridge, New Jersey, United States eTeam Full time

    Title: Marketing Consultant Location: Remote Duration: 6+ Months Responsibilities:We are looking for a talented Marketing Consultant to join our team to enhance and project manage the training materials and communication for Adobe Workfront. Your expertise will help redefine the usability and interface of the Workfront platform, ensuring different teams...

  • Associate Director, Global Project Management

    2 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence...

  • Tech CoE Automation Architect

    3 weeks ago

    Basking Ridge, New Jersey, United States Cognizant Full time

    Cognizant Technology Solutions is currently seeking a highly skilled QE Automation Architect - Tech CoE who will be responsible for Design and lead QA transformation initiatives at enterprise level and involved in Technical Solutioning. Ready to be a change-maker and challenge the way they work today will lead the way tomorrow Ability to work independently...

  • Tech CoE Automation Architect

    4 weeks ago

    Basking Ridge, New Jersey, United States Cognizant Full time

    Cognizant Technology Solutions is currently seeking a highly skilled QE Automation Architect - Tech CoE who will be responsible for Design and lead QA transformation initiatives at enterprise level and involved in Technical Solutioning. Ready to be a change-maker and challenge the way they work today will lead the way tomorrow Ability to work independently...

  • Tech CoE Automation Architect

    7 days ago

    Basking Ridge, New Jersey, United States Cognizant North America Full time

    Cognizant Technology Solutions is currently seeking a highly skilled QE Automation Architect - Tech CoE who will be responsible for Design and lead QA transformation initiatives at enterprise level and involved in Technical Solutioning.Ready to be a change-maker and challenge the way they work today will lead the way tomorrow Ability to work independently...

  • Director, GMA Oncology Center of Excellence

    3 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence...