Supply Chain Planning Analyst|ALX|US
Apollo Professional Solutions
- New Haven, CT
- $66.20 per hour
- Contract
- Full-time
New Haven CT*
Contract - 5/40
Pay Rate: $66.20/Hr.
Benefits: medical, dental, vision, 401k
*100% remote or on-siteEducation: Supply Chain Planning Analyst
1. US Citizenship
2. Bachelor's degree with relevant experience, or a lower degree with 1-2 years of experienceJob Description: Supply Chain Planning Analyst
Contributes to the planning and ongoing delivery of investigational products by managing the supply chain, supporting the execution of studies and changes to the plans, including carrying out risk assessments and contingency planning where necessary, in support of Clinical Therapy Area and non Clinical Therapy Area projects. This is a Clinical Supply support role position, working directly with the Clinical Supply Manager to complete documentations in support of varying clinical activities.Duties: Supply Chain Planning Analyst
GCS Document Specialist Day-to-day Operations
1. Collaborate with CSMs on maintenance of GCS operations-related documents for all active and upcoming studies (list below) Examples: checking for most current document versions, ensuring approval completeness, maintaining list of key study contacts, etc 2. Ensure accuracy and completeness of GCS study documents in team storage space (BOX and Sharepoint) by performing regular filing, review, and organization of controlled documents. 3. Assist CSMs in managing document review and approval in DocuSign/ Adobe e-Sign
4. Interface with internal Alexion functions and external vendors (Almac, Catalent, PCI, Endpoint, etc) to obtain and maintain GCS study documents generated in day-to-day GCS operations.
5. Streamline process for document storage and archiving across GCS studies by identifying and driving areas of improvement.Inspection Readiness Support
1. Support CSMs during audit and inspection activities by compiling and requesting study documents in anticipation of auditor/inspectors requests. a. Typically documents not already in BOX study folders. 2. Collaborate with TMF specialist to ensure all TMF filings are accurate and contemporized for all GCS studies, particularly ahead of study audits and inspections 3. Assist CSMs with Storyboard creation and maintenance via communicating with involved functions and reviewing related study documents and/or TrackWise reports.Potential Areas of Support
1. Act as the GCS POC for document storage transition from client BOX to different client BOX and OneDrive
2. Create and maintain GCS documents in Vault, the GMP environment
3. Assist with PO requests in terms of Smartsheet submission and quote approval in Coupa.Key GCS study documents:Packaging/Labeling/Distribution
Request for Packaging (Blinded and Unblinded RFP), Variable Data Request, Label Links and Rand, Packaging Specifications (PS), Certificate of Compliance/Conformance (CoC), Certificate of Analysis (CoA), Certificate of Testing (CoT), Partial Manufacturing Certificate, QP certificates, IMP release Certificates, Global Distribution Specifications (GDS), Drug Return Instructions (DRI), Certificate of Destruction (CoD)IRT:
RT specifications (Endpoint PULSE and Almac IXRS), Endpoint DRIVE Specifications, User Acceptance Test (UAT) Log, IRT User guides, DRIVE User Manual, Drug Return Instructions (DRI), Data Change Requests (DCR), IRT Report for Returns Discrepancy, IRT Validation Certificate Audit trail report requests for site/user changes for audits and inspections Study Maintenance:
Study Protocol, Pharmacy Manual (PM), Vendor Oversight Plan (VOP- GCS and study-level), Meeting Minutes, Purchase Order (PO) requests, Clinical Supply Agreement (CSA)Quality (with GCSQ and external QA):
Vendor Deviation Reports
CSR:
Appendix 16.1.6 (study lot information)
Vault (Tentative):
Clinical Label Approval Document (CLAD), Finished Product (FP) Specifications, Standard Operating Procedure (SOP) updates and lifecycle management.72111
EEO Statement Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.