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

Archive Senior Specialist, Global Quality Systems and Compliance

General Summary:

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. 

Key Duties and 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.

Knowledge and Skills:

• 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 using record management systems (SoftExpert) and electronic archival systems (Arkivum) preferred.
• 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).
• Ability to adapts work approach to familiarize cross functional areas on archive requirements.

Education and Experience:

• Bachelor's degree in relevant field is required or the equivalent combination of education and experience
• Typically requires 3 years of experience
•  

$46-$49/HR

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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No C2C or Third-Party Vendors