Technical Writer (GMP)
Batch Record Review & Deviation Investigation

Location: Hybrid/Oklahoma City, OK

Job Summary:
We are seeking an experienced Manufacturing Tech Writer with a strong background in GMP environments and technical transfer. The ideal candidate will be responsible for creating, revising, and managing Standard Operating Procedures (SOPs), batch records, and other documentation to ensure compliance with regulatory standards. You will also serve as the point person for managing and completing deviation and Corrective and Preventive Action (CAPA) paperwork.
Key Responsibilities:

• Develop and write clear, concise SOPs, batch records, and manufacturing process documentation from scratch.
  

• Review, revise, and maintain technical documents to ensure they meet current GMP, regulatory, and quality standards.
  

• Act as the lead writer for technical transfer projects, ensuring accurate and comprehensive documentation of processes.
  

• Collaborate with cross-functional teams, including Quality, Engineering, and Manufacturing, to gather technical information for documentation.
  

• Serve as the primary point of contact for preparing and completing deviation reports and CAPA documentation.
  

• Ensure documentation is in compliance with FDA, EU, and other regulatory standards.
  

• Support the implementation and revision of document control processes.
  

• Participate in audits and inspections by providing required documentation and ensuring its accuracy.
  

• Assist in training manufacturing and quality staff on new and revised procedures.

Qualifications:

• Bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, or Technical Writing).
  

• 3+ years of experience writing SOPs, batch records, and GMP documentation in a regulated environment (pharmaceutical or biotech industry preferred).
  

• Proven experience with technical transfer projects.
  

• Familiarity with deviation and CAPA processes.
  

• Strong understanding of GMP regulations (FDA, EU, etc.).
  

• Excellent writing, editing, and organizational skills.
  

• Ability to work independently and in a hybrid environment.
  

• Strong attention to detail and the ability to manage multiple tasks effectively.

Job Details:

• M-F; 8am-5pm
  

• Long term contract
  

• Hybrid
  

• Competitive Salary/Benefits Package

Preferred:

• Experience with document management systems (e.g., MasterControl, Veeva).
  

• Experience with change control processes.

This role requires attention to detail, problem-solving skills, and the ability to handle multiple investigations simultaneously. The ideal candidate will have a strong background in technical writing, deviation management, and experience within pharmaceutical manufacturing.

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