Job Description

Must Haves:

• Bachelor's Degree in related field
• 3-5 years of Technical Writing experience in pharmaceutical or biotechnology industries
• Experience reviewing, editing, and improving SOPs and MBRs

Job Description:

We are seeking a Technical Writer to join the Manufacturing Operations organization at a large pharmaceutical client based out of Andover, MA. The Technical Writer will be responsible for breaking down lengthy and complex SOPs into a separation of set up, operational execution, and post operation documentation. This is to ensure the governing SOPs are easily managed from both a training perspective and ease of execution for operators on the floor. The goal of this project is to unify and standardize these SOPs and MBRs to provide clearer communication between different Suites and shifts.

Responsibilities:

• Perform impact risk assessment as well as assist in root cause determination and plans appropriate corrective action and preventative action.
• Ensure Quality Management System for the investigations department are followed and maintained.
• Conduct and write formal investigation reports with varying degrees of complexity with the assistance of plant personnel and oversight from Lead/Manager
• Frequently enters the production area wearing appropriate gowning as necessary, to collaborate with colleagues and gather information for each investigation.
• Prior investigation writing experience (with determination of product impact).
• Plans appropriate corrective action and preventative action (CAPA).
• Perform reviews and evaluate sensitive, confidential information and develops recommendations for use by the plant quality assurance department.
• Defining and recommending corrective and/or preventive actions identified through the investigation process.
• Facilitates strategy meetings.

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