Technical Writer

JOB SUMMARY:

Support Quality Control with written documentation management. Create new or revise existing content for regulatory documentation and compile data in accordance with industry best practices, cGMP requirements and corporate guidelines. Work collaboratively with team members including Quality Assurance, Document Control, and other subject-matter experts (SMEs) to solidify content.

RESPONSIBILITIES:

• Provide inter-departmental support with written documentation, including Material Inspection Records and Product Testing Specifications (Intermediate/Filling).
• Review, edit, standardize, or make changes to material prepared by other writers or facility personnel as instructed by Area SMEs.
• Organize material and complete writing assignments according to set standards regarding order, clarity, conciseness, style, and terminology.
• Work with various department personnel to gain understanding of equipment/procedures/processes and translate into written procedures.
• Understand different user levels and write documents that meet the need of the end user.
• Keep record and provide updates on document deliverables to project owner and ensure that documents are delivered to the customer (either internal or external) in a timely manner.
• Performing other duties as assigned.

REQUIREMENTS:

• The ability to manage multiple projects at a time.
• The ability to communicate well with others through speech and text
• Process complex thoughts and communicate them efficiently to the end user. Must be able to work independently as well as in a team environment.
• Good command of MS Office Suite (Word, Excel, PowerPoint, and Outlook).
• Strong working knowledge of editing, proofreading, spelling, grammar, formatting and punctuation.
• Proficient in computer and software literacy.

PREFERRED ADDITIONAL:

• Experience in cGMP environment.
• Experience in a Quality Laboratory a plus
• Experience in an agile team working in a fast-paced environment.
• Bachelors degree or experience equivalent to Duties/Responsibilities for a minimum of 2 years.
• Knowledge in interpreting and implementing quality documents/specifications applicable to documentation update.