Innova Solutions is immediately hiring for a Supply Chain Planning Analyst

Position type : Full-time Contract

Location : (Remote)

Duration : 12 Months

Note :

• Supply chain planning, shipment documentation experience
• Vendor form and quality investigation
• Must have clinical supply experience

As a Supply Chain Planning Analyst, you will :

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 functions and external vendors 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

Potential Areas of Support

1. Act as the GCS POC for document storage transition from 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 :

• IRT 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

Note :

• Supply chain planning, shipment documentation experience
• Vendor form and quality investigation
• Must have clinical supply experience

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PAY RANGE AND BENEFITS :

Pay Range* : Pay Range : $64 - $66 per hour.

Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits : Innova Solutions offers benefits( based on eligibility) that include the following : Medical & pharmacy coverage, Dental / vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

Last updated : 2024-05-13