cGMP Analytical Development Technical Writer

Cambrex - Charles City; Charles City (IA); On-site; USD 60,000 - 80,000; Full time

Job summary

Cambrex - Charles City is seeking an AD Technical Writer to generate high quality technical documents such as test procedures, protocols, and reports based on data from the Analytical Development group. The role requires adherence to cGMP, EPA, FDA and other regulatory guidelines.

Responsibilities include drafting, revising, and approving documents using MasterControl and TrackWise, compiling data from notebooks and instruments, and collaborating with AD, QC, and QA to meet evolving business

Qualifications

• Drafting and revising controlled documents such as test procedures, protocols, reports, and SOPs.
• Coordinate the approvals of documents using MasterControl and TrackWise.
• Compile data from laboratory notebooks and instrumentation software for reports.

Responsibilities

• Draft and revise controlled documents following guidelines for correctness, completeness, clarity, and format.
• Coordinate approvals through MasterControl and TrackWise.
• Compile and present data from multiple sources.
• Maintain communication with AD, QC, and QA to ensure timely delivery of high quality documents.
• Improve documentation systems to increase efficiency and compliance.

Skills

Technical writing

Regulatory knowledge

Education

Bachelor’s degree in Chemistry or related field

Tools

MasterControl

TrackWise

Job description

Cambrex - Charles City is seeking an AD Technical Writer to generate high quality technical documents such as test procedures, protocols, and reports based on data from the Analytical Development group. The role requires adherence to cGMP, EPA, FDA and other regulatory guidelines.

Responsibilities include drafting, revising, and approving documents using MasterControl and TrackWise, compiling data from notebooks and instruments, and collaborating with AD, QC, and QA to meet evolving business