Technical Writer III

What will you do?

Our company seeks a Technical Writer and Investigator that investigates and responds to Quality Management System deviations and complaints to ensure root causes are identified and action plans are initiated to reduce the likelihood of recurrence. An ideal candidate has strong written and verbal communication skills and must be able to write technical concepts clearly and concisely with good punctuation and grammar to enable clients to effectively analyze product impact.

Responsibilities

• Conducts all activities in a safe and efficient manner.
• Applies Good Manufacturing Principles in all areas of responsibility.
• Demonstrates and promotes the company vision.
• Performs duties through guidance from a more senior technical writer and investigator.
• Composes technical concepts in a clear and concise manner to enable clients to analyze product impact and ensure prevention of reoccurrence.
• Investigates and responds to Quality Management System deviations and complaints to ensure root causes are identified and action plans are initiated to reduce the likelihood of recurrence.
• Conducts in-depth interviews to obtain and document accurate information.
• Effectively completes CAPAs and effectiveness checks within the Quality Management System.
• Establishes recommendations for changes to Standard Operating Procedures (SOPs) and associated documentation (i.e. protocol risk assessments).
• Other duties may be assigned to meet business needs.

Knowledge, Skills, Abilities

• Must be able to write technical concepts clearly and concisely with good punctuation and grammar to enable clients to effectively analyze product impact.
• Experience in Microsoft Suite (i.e. Excel, Word, PowerPoint).
• Ability to read and interpret GMP and other regulatory requirements.
• Ability to work effectively and accurately in a fast-paced environment.
• Must possess the ability to define problems, collect data, establish facts, and draw valid conclusions.
• Must be able to utilize Root Cause Analysis techniques to identify and describe (write) the root cause and critical contributing factors to the event.
• Must be able to work with subject matter experts to identify and document the Corrective and Preventative actions that will minimize the risk of a repeat occurrence of the event.
• Must be able to effectively interact with internal contacts at all levels company-wide (IT, QA, Operations, Client Services, Supply Chain, etc.).
• Must have the ability to effectively present information and respond to questions from senior management, peers, and clients.
• Able to work independently and in a team environment.
• Strong written and verbal communication skills.
• Excellent prioritization skills.
• Task and detail oriented.
• Independent problem solver.
• Ability to multi-task/manage multiple projects and strong ability to drive tasks/projects to closure by project deadline.
• Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.

Physical Requirements

Must be able to physically perform duties of position which include: Exert up to 10lbs of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. Position may involve prolonged sitting but may involve walking or standing for brief periods of time. May need stoop, reach or bend.