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Intern, Quality Systems & Compliance

The summer internship program offers a unique perspective into a world-class pharmaceutical company.  Our internship program also provides the opportunity to network with people at Alkermes through various planned events and activities.  Interns will be involved in a wide range of activities during their 12 week experience. This will include participation alongside employees during engagements. The role will include, but is not limited to, the following responsibilities: 


Partners with QS&C team members to analyze the business requirements for information systems and solutions; and translate then into subjective test cases for testing. 
Provides support for application software solutions; works with business analysts and technical experts on the solution requirements, configuration, gap resolution, implementation, support, maintenance and enhancement of the applications.
Supports the development of procedures, training materials and validation documentation to ensure all information documented is accurate.
 

Project Support:
o    Applies project management skills within an area of business or technical specialty
o    Provides administrative and logistics support for project team and project manager
o    Meeting minutes support for project workshops
o    Following up on assignments and providing status reports to QS&C functional lead or delegate.
o    To support configuration and testing to ensure that systems configured are per intended use.
 

Additional responsibilities could include:
o    With guidance, assisting in implementing improvements to the documentation system and records retention process.
o    With guidance, initiating and managing documentation changes to completion.
o    Building Computer Based Training Modules with oversight and content support.
o    Following up on assignments and providing status reports to QS&C management.


Qualifications
o    Experience in each of the following MS Office applications:
o    MS Outlook - Proficient
o    MS Word - Proficient
o    MS Excel - Proficient
o    MS PowerPoint – Proficient
o     Must be deadline driven and have a high level of organizational and prioritization skills
o    The ideal candidate exhibits strong analytical, problem-solving, oral and written communication skills and is detail oriented. The candidate must possess the ability to work well in teams and effectively support multiple projects.


Education & Experience 
Education needed and years of experience should be included
o    Applicants must be enrolled in a U.S. accredited university for a year before starting the program.
o    Applicants must be pursuing a Bachelor’s degree either in Technical field with experience in computer systems or life science field is preferred.
 

What You Should Know About Intern, Quality Systems & Compliance, Alkermes

Are you ready to kickstart your career in the pharmaceutical industry? Join Alkermes as an Intern in Quality Systems & Compliance in Waltham, Massachusetts, where you'll gain unrivaled experience over a 12-week summer internship program! You'll have the chance to network with professionals and contribute to meaningful projects alongside our talented QS&C team. Your responsibilities will include analyzing business requirements for information systems, translating them into effective test cases, and providing support for various application software solutions. As you collaborate with business analysts and technical experts, you'll help ensure our systems are configured for their intended use while developing training materials and validation documentation. You'll also hone your project management skills by supporting logistics, preparing meeting minutes, and providing status reports. This is not just an internship; it's an opportunity to make a difference while developing essential skills in a dynamic environment. We're looking for a detail-oriented, analytical intern who can juggle multiple projects and has a strong command of MS Office applications. If you're pursuing a Bachelor's degree in a technical or life sciences field and have the ability to work well in teams, we'd love to hear from you!

Frequently Asked Questions (FAQs) for Intern, Quality Systems & Compliance Role at Alkermes
What will I do as an Intern in Quality Systems & Compliance at Alkermes?

As an Intern in Quality Systems & Compliance at Alkermes, you'll take on a variety of responsibilities, including analyzing business requirements for information systems, translating them into test cases, and supporting application software solutions. You'll work closely with business analysts to ensure everything runs smoothly and efficiently. Additionally, you'll assist in developing training materials and validation documentation while supporting project management activities, which will give you valuable insight into both the operational and technical aspects of the pharmaceutical industry.

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What qualifications are required for the Intern position at Alkermes?

To qualify for the Intern position in Quality Systems & Compliance at Alkermes, you must be enrolled in a U.S. accredited university and have completed at least one year of study. It's preferred that you're pursuing a Bachelor's degree in a technical field related to computer systems or life sciences. Strong analytical skills, proficiency in MS Office applications, and the ability to effectively communicate are essential, along with having excellent organization and prioritization skills in a team environment.

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How can I prepare for the Internship at Alkermes?

Preparation for your internship at Alkermes starts with brushing up on your MS Office skills and familiarizing yourself with basic project management principles. Review the responsibilities and tasks outlined in the internship description to understand what to expect. It might also be helpful to learn about the pharmaceutical industry and Alkermes' role in it. Additionally, developing your organizational and communication skills will set you up for success in this collaborative environment.

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What kind of projects will I work on during my internship at Alkermes?

During your internship in Quality Systems & Compliance at Alkermes, you can expect to work on various projects that may include analyzing business needs for software solutions, participating in system configuration, and contributing to documentation processes. You'll support existing projects and may also have the opportunity to initiate improvements, all while gaining firsthand experience in the pharmaceutical sector. This hands-on experience will provide invaluable skills as you further your career.

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What is the work environment like for interns at Alkermes?

The work environment for interns at Alkermes is supportive and collaborative, designed to encourage personal and professional growth. You will be surrounded by knowledgeable professionals who are eager to share insights and help you develop valuable skills. Regular networking events and activities will also enhance your internship experience. The culture at Alkermes fosters innovation and teamwork, ensuring that you get the most out of your time with us.

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Common Interview Questions for Intern, Quality Systems & Compliance
How do you prioritize tasks while working on multiple projects?

When faced with multiple projects as an intern in Quality Systems & Compliance, I prioritize tasks by assessing deadlines, the impact on ongoing projects, and the overall objectives of the team. Communication with team members is key in understanding which tasks are urgent and which can be scheduled over a longer timeframe.

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What experience do you have with information systems and testing?

While I may not have direct professional experience, I have a strong foundation in understanding information systems through my coursework and projects in my Bachelor's program. I am familiar with the testing process, including creating test cases and validating software functionality, and I am eager to apply and expand this knowledge during my internship.

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Can you provide an example of a time you worked in a team?

Yes! In one of my college projects, I collaborated with teammates to create a presentation on data analysis. We divided the responsibilities according to each person’s strengths and held regular meetings to discuss our progress. This experience taught me the importance of communication and flexibility in a team setting, which I believe is vital for my role at Alkermes.

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What tools and software are you familiar with related to this internship?

I am proficient in MS Office applications, including Word, Excel, PowerPoint, and Outlook. I've used Excel for data analysis and reporting throughout my studies. Additionally, I'm eager to learn about specific software systems used at Alkermes and enhance my technical skills during the internship.

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How do you ensure accuracy in your work?

To ensure accuracy in my work, I double-check all documentation and data entries against original sources. I also follow any established protocols or guidelines that exist to minimize errors. Seeking feedback from peers and mentors is also an essential practice I rely on to ensure thoroughness in my work.

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What is your understanding of compliance in the pharmaceutical industry?

Compliance in the pharmaceutical industry involves adhering to regulatory standards to ensure product safety, efficacy, and quality. It includes proper documentation, validation of processes, and implementing quality management systems that uphold the integrity of the development and manufacturing processes, all vital aspects I hope to learn more about during my internship at Alkermes.

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Why did you choose to apply for an internship at Alkermes?

I chose to apply for an internship at Alkermes because I am passionate about the pharmaceutical industry and admire Alkermes' commitment to transforming the lives of patients. The opportunity to work within the Quality Systems & Compliance team aligns perfectly with my academic background and career aspirations, and I'm eager to gain practical experience in an innovative environment.

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How do you handle tight deadlines and pressure?

When faced with tight deadlines, I prioritize tasks and create a manageable timeline to ensure I stay on track. I remain focused and calm, breaking down larger tasks into smaller, more manageable steps. If needed, I'm not shy about communicating with team members to realign priorities and ensure we meet deadlines efficiently.

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What do you hope to learn during your internship at Alkermes?

During my internship at Alkermes, I hope to gain hands-on experience in quality systems and compliance processes, from documentation to project management. I am eager to learn more about the pharmaceutical industry’s regulatory environment and develop my skills in teamwork and problem-solving within a real-world context.

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How do you keep yourself organized while working on various projects?

I keep myself organized by using tools like digital calendars and task management apps to help track deadlines and deliverables. I create to-do lists to break down projects into tasks and prioritize these by urgency and importance. This helps me maintain focus and ensures I stay productive while juggling multiple responsibilities during the internship.

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DATE POSTED
April 4, 2025

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