Global Quality Assurance Systems Compliance Summer Intern Job in Chesterbrook, Pennsylvania US
Global Quality Assurance Systems Compliance Summer Intern
Kelly Services is partnering with Shire Pharmaceuticals to offer an exciting internship program with a world-class pharmaceutical organization. Shire is a global specialty biopharmaceutical company focused on the therapeutic areas of attention deficit hyperactivity disorder (ADHD), human genetic therapies, gastrointestinal (GI), and regenerative medicine. Shire?s purpose is to enable people with life-altering conditions to lead better lives. Shire's U.S. Internship Program offers hands-on work experience to students completing their undergraduate and graduate degrees and allows Shire to engage with the local community and discover new and emerging talent. Requirements for the Shire U.S. Internship Program include: Enrollment at an accredited college/university Completion of at least freshman year of undergraduate study by internship start date (Both undergraduate and graduate students that apply will be considered) Major in a field appropriate to the internship Minimum grade point average of 3.0 on a 4.0 scale preferred Legal authorization to work in the U.S. Must be at least 18 years of age Ability to start on one of the designated start dates (see calendar of events below). Please Note: Shire will accept and consider intern applications from relatives of employees; however, individuals will not be hired if they are in the direct line of supervision of a relative or if there is a work-related conflict of interest. Objectives: Assist in the Supplier Quality Management system Review and develop guidelines for ?Supplier to Shire Site? field and use of it Gap assess audit files since implementation of TrackWise Work with Systems Compliance and Document Control to develop a collaborative space for housing of QTA documents which can be handed to Doc control for future management Assist in the management of the TSE system Assist in the 3 month check of the TSE system status update Assist in the tracking, trending and follow up of the TSE/Melamine questionnaires from contractors To assist in the preparation for impending regulatory inspection Develop reference hand-outs for all impacted departments, disseminating as appropriate Assist in development and filing of reports on key systems To assist in follow-up of MHRA preparation activities Assist in the set-up and logistics of the inspection 4. To assist in the gathering of signature records, as required Work closely with Critical Documentation to ensure that signature records are 100% up to date for all Basingstoke/SPIL GSC staff. Ensure Critical Documentation Control?s requirements are fully understood and met Update local files with up-to-date signature records. To provide support for any other relevant activities within the GQA department, as required To assist in IT Compliance system and project support activities To assist Regulatory Compliance in creating and populating a repository for regulatory guidance documents. Required Skills · Good interpersonal and communication skills · Able to work professionally in an office environment · Able to promote a positive image for the Global Quality Assurance department · Able to work with many organisations / cultures / quality systems · Ability to manage multiple projects / activities and meet deadlines · Must be undertaking study in a related Life Science degree/course · Expected to work collaboratively with a number of internal customers / business units · Someone who will look for ways to logically solve problems whilst maintaining quality standards and considering business requirements · Must have good IT skills, including knowledge of Microsoft Office, Excel, Word and PowerPoint If you are interested in this fantastic Summer internship opportunity and meet the requirements of the program, apply online today! About Kelly Services Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions. Kelly® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire and direct-hire basis. Serving clients around the globe, Kelly provides employment to more than 530,000 employees annually. Revenue in 2010 was $5 billion. Visit http://www.kellyservices.com and connect with us on Facebook, LinkedIn, Twitter .