The purpose of Technical Writer role is to:

• Serve as a Technical Writer dedicated to authoring, revising and improving documents within manufacturing. 
• Serve as liaison between manufacturing groups, as well as between manufacturing and support departments, to ensure accurate, compliant and streamlined controlled documents. 
• Drive continuous improvement in the controlled document system and determine best practices that increase usability and practicality of documents.
• Champion standardization of documents across groups within manufacturing (e.g., content, structure, format, etc.)
• Serve as a change coordinator for projects in the manufacturing departments.
• Partner with learning and development as well as Manufacturing groups to ensure documents support accurate representation of operations and provide a foundation for education and competency

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

Environmental Health & Safety: 

• Promote a highly safety conscious culture and EHS focused workforce.  Perform all job responsibilities in compliance with applicable regulations, current operating procedures, and industry practice.

Quality & Compliance:

• Support integration of overarching Manufacturing systems and procedures to achieve inspection readiness at all times.  Ensure all activities are executed following quality and regulatory standards.  Support implementation and monitoring of quality systems to achieve inspection readiness at all times.  Promote a quality mindset and quality excellence approach to all activities.  Adhere to all GSK Quality Management System (QMS) policies and procedures as applicable. 
• Format and manage documents using appropriate guidelines and established document templates
• Evaluate LSOP change requests to determine scope of change, and ensure accurate information in revision history (associated CAPAs, Change Controls, Impact Assessments, etc.)
• Where appropriate, manage CAPA tasks related to LSOP revisions
• Determine when LSOP duplications exist and manage resolution and consolidation of affected documents

Continuous Improvement:

• Support Lean/Six Sigma program to drive and embed a culture of continuous improvement by the use of operational excellence methodologies to realize ever-increasing levels of value in the usability and practicality of documents 
• Partner with local Learning and Development team to drive the revision and creation of SOPs and GMP documents that enable effective training, retention of information and competency.
• Incorporate revisions and ensure consistent terminology and language for presentation of information.
• Partner with key stakeholders and drive continuous improvement in the controlled document system and determine best practices that increase usability and practicality of documents.

Accountability:

• Partner with LSOP Process Owners, to obtain accurate content for inclusion in documents, utilizing shop floor Gembas and process walk-downs, to drive inclusion of effective and accurate content in documents, and communicate significant LSOP changes in procedures to process owners
• Partner with Doc Adnims to ensure documents are submitted for upload into eSOP in an accurate, timely manner.
• Monitor document cycle time and escalate overdue tasks as required.

Change Management:

• Deal positively with change, demonstrating the ability to maintain high personal performance levels as the organization evolves.  Positively influence others’ ability to adapt to change.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's Degree in any Discipline

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Bachelor's Degree in Technical Writing degree or specialized training in technical writing
• Knowledge of cGMP, FDA and other regulatory requirements and quality systems
• Working knowledge of SAP with demonstrated ability to learn other facets of SAP (i.e. eSOP, and change control)
• Proficient use of MS Office Suite, Visio, digital imaging
• Ability to prioritize and flexibility to adapt to changing business schedules and deadlines
• Ability to coordinate projects involving multiple documents and clients
• Good communication, organizational and team skills
• Public speaking/presentation
• Ability to take initiative and work