Archive Senior Specialist, Global Quality Systems and Compliance (Contract)

Vertex Pharmaceuticals • Boston, MA

3d • $46 - $49 • Onsite

About The Position

The Quality Standards, Archive Senior Specialist will work cross functionally to deliver effective and efficient knowledge to support customer initiatives. The Senior Specialist works with a moderate degree of independence and is adept at troubleshooting a range of straightforward problems to create and execute improved internal procedures, and to ensure compliance with applicable regulatory requirements. The Senior Specialist will look for ways to continue to improve the records management archival process. This role is 100% on site. Starts with a 12 month contract and chance to extend.

Requirements

• Demonstrated ability to work under general guidance and manage multiple assignments that require collaboration across functional areas.
• Ability to work and coordinate cross-functionally.
• Good experience with and ability to use Microsoft Office and associated tools (WORD, Excel, PowerPoint)
• Experience with physical and electronic record archival such as storage management, issuance, retrieval, record retention requirements, and understanding metadata mapping.
• Experience with off site storage facilities. Facilitating the transfer of records and requesting storage and scanning of records.
• Foundational GxP knowledge with understanding of global regulations governing the records management process. Can supporting audit requests.
• Has Knowledge of CMC Documents (Master Batch Records, Analytical Methods, Specifications, etc.) and QA Controlled Documents (Standard Operating Procedures, Work Instructions, Job Aids).

Nice To Haves

• Experience using record management systems (SoftExpert) and electronic archival systems (Arkivum) preferred.

Responsibilities

• Functions as a business administrator in the GxP archives as a technical resource within their discipline; answering questions and requests related to the Archive and Document Management Systems CMC, QA) and service requests.
• Actively participates in GxP archives, including retrieval, receipt, processing, scanning, and storage of GxP records. These activities can be internally or with external vendors.
• Executes retention management lifecycle requirement for physical records and electronic records within an electronic record management system and / or electronic archive.
• Execute processes associated with the lifecycle of records in the electronic document management system such as document creation and approval.
• Continually supports related framework improvements, in line with functional area strategy. Develops and implements archival processes through standard operating procedures (SOP), work instructions (WI) and job aid deployment.
• Adapts work approach to familiarize cross functional areas on archive requirements.

Benefits

• compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior