Technical Writer III

Thermo Fisher Scientific • Allentown, PA

21h • Onsite

About The Position

The Technical Writer and Investigator investigates and responds to Quality Management System deviations and complaints, identifies root causes, and initiates action plans to reduce the likelihood of recurrence. The role writes technical concepts clearly and concisely so clients can analyze product impact. Duties are performed with guidance from a more senior technical writer and investigator. The position is with Fisher Clinical Services, part of Thermo Fisher Scientific, which provides clinical supply chain services to pharmaceutical and biotech customers worldwide.

Requirements

• High school diploma required.
• One year of experience working in a Pharmaceutical Packaging/GMP environment.
• Ability to write technical concepts clearly and concisely, with good punctuation and grammar.
• Experience with Microsoft Suite, such as Excel, Word, and PowerPoint.
• Ability to read and interpret GMP and other regulatory requirements.
• Ability to work effectively and accurately in a fast-paced environment.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to use Root Cause Analysis techniques to identify and describe root causes and critical contributing factors.
• Ability to work with subject matter experts to identify and document corrective and preventative actions that minimize the risk of recurrence.
• Ability to interact effectively with internal contacts at all company levels; limited contact with external customers.
• Ability to present information effectively and respond to questions from senior management, peers, and clients.
• Ability to work independently and in a team environment.
• Strong written and verbal communication skills.
• Excellent prioritization skills; task- and detail-oriented; independent problem-solving ability.
• Ability to multitask, manage multiple projects, and drive tasks and projects to closure by deadlines.
• Mastery of skills required to read, understand, and adhere to SOPs and policies in a GMP environment.
• Ability to perform the physical duties of the position, including occasional exertion of up to 10 pounds of force and frequent or constant exertion of negligible force; prolonged sitting; and possible brief periods of walking or standing, stooping, reaching, or bending.

Responsibilities

• Conduct all activities in a safe and efficient manner.
• Apply Good Manufacturing Principles in all areas of responsibility.
• Demonstrate and promote the company vision.
• Compose clear, concise technical concepts that enable clients to analyze product impact and help prevent recurrence.
• Investigate and respond to Quality Management System deviations and complaints, identifying root causes and initiating action plans to reduce recurrence.
• Conduct in-depth interviews to obtain and document accurate information.
• Complete CAPAs and effectiveness checks within the Quality Management System.
• Recommend changes to Standard Operating Procedures and associated documentation, including protocol risk assessments.
• Perform other duties as assigned to meet business needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED