Technical Writer

Quality Seymour, Indiana


Description

Job Summary:

This position is viewed as a resource in generating GMP documents. Possess strong technical writing skills and understanding of manufacturing and packaging concepts in the pharmaceutical field. Responsible for generating GMP documents (manufacturing and packaging batch records) with limited supervision and directions from the senior staff and/or management.

Able to communicate verbally and in writing clearly and concisely. Carries out assignments and responsibilities and achieves objectives within expected time frames through own effort with an appropriate level of supervision. Able to prioritize work and brings assignments to a reasonable state of completion commensurate with job expectations.

Responsibilities:  

• Assist with preparation of new GMP documents (MBRs, PBRs, templates, forms, etc.) with input from subject matter experts.
• Review existing GMP documentation to validate for clarity, format consistency, completeness and overall quality.
• Edit/update GMP documents through change control systems.
• Assist TS group with preparation of CMC documents to support submissions to agency (eCTD sections).
• Able to recognize issues related to job that may require escalation to management issues.
• Author and/or assist with departmental policies for compliance.
• Author and/or assist with job-related SOPs.
• Work in collaboration with TS management, scientists and production personnel to gain knowledge in pharmaceutical manufacturing.
• Collaborate with cross-functional groups within the site to achieve project goals and meet the timelines

Education and Experience:

• 3-8 years of experience in document writing. 
• Experience as a Technical Writer in a cGMP regulated environment writing documentation in support of audit and compliance activities is highly desirable. 
• Bachelor’s degree or advanced degree in lieu of experience.

Specific Skills:

• Perform other job-related duties as assigned to meet departmental and company objective
• Able to generate high quality GMP documentation (MBRs and PBRs).
• Competent in English (both written and verbal). Strong technical writing skills with attention to detail and verbal/written communication skills.
• Proficiency with MS Word. MS office skills with Excel, PowerPoint, and Access are highly preferred.
• Basic knowledge of data management systems (Master Control, SAP, etc.) commensurate with job expectations.
• Understanding of manufacturing/packaging concepts in the field.
• Demonstrate adherence to company policies/procedures, compliance/regulatory mandates and quality requirements.
• Team Player with great communication skills. 

Physical Requirements:

N/A