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Form of workJob Description
Job Description:
Pay Range $41hr - 44hr
Responsibilities:
Pay Range $41hr - 44hr
Responsibilities:
- Supporting deviations, investigations, and CAPAs related to warehouse and logistic activities.
- Assisting Clinical Supply Chain Quality and Logistics operations during internal audits, regulatory agency inspections, and third-party inspections, including warehouses in the Clinical Supply Chain Logistics network.
- Supporting Vendor Quality Management, including qualification activities as assigned.
- Drafting and coordinating Quality Agreements related to Clinical Supply Chain Vendors.
- Assisting with additional labeling activities at warehouses, including review, approval, and release.
- Managing supplies within the SAP System.
- Reviewing procedural documents.
- Supporting Change Control processes as needed.
- Providing instruction and guidance on quality issues and serving as a resource for the business functions.
- Possessing knowledge of regulatory requirements related to GMP/GDP activities performed at supported warehouses.
- Bringing any information relating to the impact of regulatory changes to the attention of Quality Management.
- By fulfilling these responsibilities, candidates will play a crucial role in ensuring the quality and compliance of the Company Clinical Supply Chain.
- B.S. in related sciences or supply chain/logistics with 5 years experience in the pharmaceutical industry within a regulated GMP and/or GDP function.
- Experience within a QA role is an asset.
- Broad experience in the supply chain, manufacturing and distribution of sterile and nonsterile products.
- In-depth knowledge of GMP/GDP regulations.
- Strong interpersonal and organizational skills.
- Demonstrated leadership skills.
- Effective written and verbal communication.
- Spanish Fluency is an asset, but not required.
- Computer proficiency such as; Microsoft Office, Inventory Management System (SAP), Quality Management System (Veeva).
