Scientist, Quality Operations

At GlaxoSmithKline, scientists in Research and Development are committed to capturing this moment. They bring to it their own very considerable abilities, the resources of a parent company devoted to the scientific enterprise, and the urgency of knowing that their highest purpose is the relief of human suffering. In pursuit of this purpose, they desire to make of GlaxoSmithKline a magnet for others who share their talents, whether as prospective corporate colleagues or as collaborators in industry, academia, and government.

 

Minimum Requirements: 

 

GlaxoSmithKline is dedicated to an innovative workplace and supports you with career long opportunities and learning. We offer a competitive benefits and compensation package designed to attract and retain the very best.

 

Description:

 

This is a support role within the Chemical Development (CD)Business Operations unit. The role is focused on the implementation and maintenance of quality and documentation components of the CD quality system. The individual will (1)support the collection and collation of data used to define and delineate key business processes (2) support administration of US specific CD SOPs, Policies, etc. (3) support administration and maintenance of GMP training matrices for CD staff and (4) support local CD lines as needed during internal compliance audits. An additional opportunity exists to support the Technical Sourcing Group in the writing and/or review of 3rd party contractor quality agreements as well as the ongoing review of change control processes and other quality related work performed by the 3rd party.

 

Requirements:

 

Degree in scientific discipline, ideally chemistry with at least 3-4 years relevant experience; or post graduate degree with 1-2 years experience; or 7 years significant equivalent work experience without a degree.

Proven experience in understanding and complying with pharmaceutical industry processes and relevant regulations (e.g., 21CFR 210 and 211, ICH Q7A, etc. within the R&D environment.

Knowledge of the pharmaceutical drug development process.

Demonstrated ability to operate with minimal supervision and deliver on tight timelines. Excellent team working, networking, and communication skills. Demonstrated systematic, analytical, and logical way of working.

 

Preferred Qualifications: 

 

Experience creating/editing process maps/flow charts and use of other Lean/Six Sigma tools. Experience handling/reviewing SOPs across multiple sites, line units. 1-2 years experience using Documentum/Workspace.Experience working with third-party contractors in the pharmaceutical industry. Experience writing/reviewing quality agreements/technical terms of supply or equivalent documents.Well-versed in the use of MSExcel, MSWord, Lotus Notes/Lotus Notes databases (e.g., ConnectWare) and Visio or equivalent application. 

We offer a competitive total compensation package as well as an environment conducive to personal and professional growth.

No agency referrals please.

Developing talent through equality of opportunity, M/F/D/V.

For confidential consideration and efficient processing, please apply online at: http://careers.peopleclick.com/client_gsk/BU1/EXTERNAL1931/newcandidate.asp?Source=MONSTER&JobID=34119

 

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