Quality Assurance GMP Training Intern
Quality Assurance GMP Training Intern
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1 Vacancy
Job Description
MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibodybased technologies. Our team of350 dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer.Our products and platforms have attracted multiple partnerships with leading pharmaceuticaland biotechnologycompanies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics corporate culture promotes an atmosphere of innovation open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.
Summary of Position
We are seeking an enthusiastic and motivated intern to join our Quality Assurance (QA) team and assist in the development of computerbased training (CBT) modules for Good Manufacturing Practices (GMP) with a focus on deviation investigations and root cause analysis. This is a unique opportunity for an intern to gain handson experience in elearning development instructional design and compliance training in a highly regulated industry.
As an Instructional Design/ELearning Development Intern you will work closely with subject matter experts (SMEs) to create engaging interactive and effective training materials that ensure employees are equipped with the knowledge to handle deviations and perform root cause analysis within GMP guidelines.
Responsibilities and Job Duties
- Assist in Designing and Developing ELearning Courses by collaborating with SMEs to develop CBT modules focused on deviation investigations and root cause analysis in GMP environments. This may include storyboarding and outlining course content creating interactive scenarios quizzes and knowledge checks designing graphics infographics and multimedia elements (e.g. videos animations).
- Work closely with GMP compliance experts and quality assurance teams to ensure technical accuracy in training content related to deviation management and root cause analysis.
- Assist in applying the Kirkpatrick Training Evaluation Model to gather feedback from learners and stakeholders evaluate the effectiveness of the training across all four levels (Reaction Learning Behavior Results) and recommend improvements based on the findings.
- Utilize ELearning Authoring Tools (e.g. Articulate Storyline Adobe Captivate Lectora) to create visually appealing interactive and userfriendly online courses.
- Assist in Content Development by creating clear concise and engaging content for training modules ensuring alignment with GMP guidelines deviation investigation procedures and root cause analysis methods.
- Test and Review Training Modules to ensure they function properly across various devices
- Assist in uploading completed training materials to the Learning Management System (LMS) (e.g. MasterControl) ensuring proper tracking and reporting functionality for learner progress.
Minimum Qualifications
Education Certifications & Experience
Currently enrolled in or recently graduated from a degree program in Instructional Design Educational Technology Life Sciences (Biology Chemistry Biotechnology) Pharmaceutical Sciences or a related field.
No professional experience required though any academic projects or internships related to instructional design elearning or pharmaceutical training are a plus.
Knowledge Skills and Abilities
- Familiarity with instructional design principles (ADDIE model or similar frameworks) and course development.
- Experience with elearning development tools (e.g. Articulate Storyline Adobe Captivate) is a plus.
- Proficiency with graphic design software (e.g. Adobe Photoshop Canva) and video editing tools (e.g. Camtasia Audacity) for creating and editing multimedia content.
- Strong communication skills to work with subject matter experts and stakeholders and to convey complex concepts clearly in training materials.
- Ability to work independently and collaboratively in a team environment with attention to detail and strong time management skills.
- Proficient in Microsoft Office Suite (especially PowerPoint and Excel) for content development planning and project tracking.
- Creative problemsolving skills to develop engaging interactive and effective training content.
Preferred Qualifications
- Familiarity with SCORM and AICC standards for elearning.
- Basic knowledge of HTML/CSS or JavaScript for custom elearning content.
- Prior experience in instructional design adult learning principles or developing elearning content is a plus.
Additional Information
The hourly rate of pay for this position is $21.50. For nonexempt roles and according to applicable regulations there may be the possibility for overtime pay. Eligible intern employees may participate in the 401(k) plan with employer match and may receive the company holiday benefit if the holiday falls on a regularly scheduled workday. An intern will accrue one hour of sick leave for every 30 hours of working time. Interns are responsible for their own travel housing and living expenses.
The pay rate range is described in good faith and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidates experience qualifications geographic location and other factors permitted by law. The Company may ultimately pay more or less than the posted range and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned vested and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus commission benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.
Statement
MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race color national origin sex gender identity sexual orientation religion age disability protected veteran status or any other characteristic protected by federal state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the employment process please email or calland/or 711 for TTD/TTY service.
Equal Opportunity Employer/Veterans/Disabled
We do notaccept nonsolicited resumes or candidate submittals from search/recruiting agencies.
Required Experience:
Director
Employment Type
Full-Time
