ASSOCIATE TECHNICAL WRITER

Fresenius - Wilson, NC

Full-time

Wilson, NC

Ambulatory Health Care Services

About the position

The Technical Writer at Fresenius Kabi is tasked with the critical responsibility of independently investigating and reporting on deviations in processes, addressing customer complaints regarding finished products, and producing various documents as assigned. This role is essential in ensuring that all documentation meets the required standards and complies with company policies and regulatory requirements. The Technical Writer will engage in the initiation and implementation of change controls through the internal change control process, utilizing the Trackwise investigation system to open and investigate issues while implementing corrective actions as necessary. In addition to these responsibilities, the Technical Writer will be involved in initiating and implementing cost improvement initiatives and supporting new product introductions through technical transfers. A significant part of the role includes reviewing and auditing master batch records, which involves running reports using Vantage Point/Dameware and entering data into Excel for annual product reviews. The Technical Writer is also responsible for completing on-time department training and ensuring compliance with company policies, training requirements, cGMPs, and safety standards. The position may require performing other duties as assigned, emphasizing the need for flexibility and adaptability in a dynamic work environment.

Responsibilities

• Initiate and implement change controls through the use of internal change control process.
• Use Trackwise investigation system to open/investigate issues and implement corrective actions.
• Initiate and implement cost improvement initiatives.
• Implement required changes for new product introductions in support of tech transfer.
• Review/audit master batch records to include running reports using Vantage Point/Dameware and entering data into Excel safe for annual product reviews.
• Complete on-time department training.
• Utilize Word, Excel, Documentum and other electronic systems to complete tasks.
• Maintain compliance with company policies, training requirements, cGMPs and safety standards.
• Perform other duties as assigned.

Requirements

• Bachelor's degree or equivalent experience.
• Requires advanced critical thinking and expert writing skills.
• One to two years of experience in a GMP manufacturing environment, writing standard operating procedures and protocols and/or reports is also required.
• Must be familiar with US FDA regulatory requirements.
• Good organizational, communication, and interpersonal skills are necessary.

Benefits

• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Vision insurance
• Wellness program