Project Coordinator Extended Outsourcing

Almac Group is currently seeking a Project Coordinator – Extended Outsourcing for our Groton, CT location (can sit in the Souderton, PA location). The Project Coordinator – Extended Outsourcing will support Global Clinical Supply as it relates to transactional and project activities.Responsibilities include but are not limited to:Use tools and systems (e.g. CSDS, Clinicopia, M3, GMDS, PTMF) to provide transactional support. Activities may include, but are not limited to:Creation of GMP documentation, such as Import Strategy Forms (ISF) and Stock Pack Requests (SPR),Approval of High-Risk Data Change Requests (DCRs)Searches for Certificate of Analysis (CoA)Coordination of Label Expiry updatesEnter and verify information in CSDSTrack and create metrics on Suspected Quality Events (SQEs)Ensure Training Compliance for Global Clinical SupplyProvides PTMF services. Partner with Supply Chain Leaders (SCLs) to create and maintain Drug Plans and API trackersPrepare and/or verify inspection readiness documentation in preparation for regulatory audits and inspectionsPerform annual reviews on ongoing studies by verifying documents against items loaded to the PTMF systemOther projects as identified by the Operations Supervisor or GCS Operations ManagerQualifications:Required Experience / Education: High School Diploma/GED and equivalent work experience requiredBachelor’s with 6+ months customer and/or community service experience or an Associate degree with 2+ years’ work experience or HS / GED with 4+ years’ work experienceWorking in ERP computer systemsPreferred Experience / Education:Bachelor's Degree in Science or business-related field preferredPharmaceutical or clinical supplies industry experienceProject management experience within a manufacturing environment preferredWhat Almac Group can offer YOU! Full medical, vision & dental benefits the 1st of the month after start date20 daysof PTO to start plus 12 holidays per yearCompany paid long and short term disability along with life insurance401k company matchProfessional development programs/ continuous learning opportunitiesWant to see our latest job opportunities? Follow us on LinkedInAlmac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years now employing almost 5,600 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. ‘Partnering to Advance Human Health’ is more than just a tagline – it is our way of life.Embracing diversity is at the heart of enhancing Almac Group’s unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all. Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV’s not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.EEO is the LawEEO is the Law GINA SupplementAlmac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at View email address on click.appcast.io to request assistance.