Analytical Development Documentation Specialist

Cambrex; Charles City (IA); On-site; USD 60,000 - 90,000; Full time

Job summary

Cambrex is seeking an AD Technical Writer to generate high quality technical documents—test procedures, protocols, and reports—based on data from the Analytical Development department. Role requires adherence to SOPs, cGMP, ICH, and regulatory guidelines.

You will draft, review, and finalize controlled documents and coordinate approvals using MasterControl and TrackWise. Bachelor’s degree in Chemistry and 2+ years in a cGMP lab are preferred.

Qualifications

• Advanced technical writing skills and the ability to communicate effectively with peers, department management, and cross-functional coworkers.
• Fluent in written English.
• Familiarity with compliance requirements within cGMP with an emphasis on method validation and reporting requirements preferred.
• Demonstrated excellence in advanced word processing using Microsoft Word.
• Demonstrated computer literacy, including spreadsheets, structural drawings, databases, and communication packages preferably in a Windows environment.
• Ability to work in a highly independent and self-directed work environment.

Responsibilities

• Drafting and revising controlled documents such as test procedures, method evaluation protocols, reports, and SOPs while following established guidelines for correctness, completeness, clarity, and format.
• Coordinate the approvals of these documents through the use of software such as MasterControl and TrackWise.
• Compile and present data from multiple sources such as laboratory notebooks and various laboratory instrumentation software.
• Maintain open communication with members of AD, QC, and QA to ensure timely delivery of high quality documents to support evolving business needs.
• Continuously improve documentation systems to increase efficiency and compliance with cGMP and/or other regulatory requirements.

Skills

Advanced technical writing

Fluent English

cGMP compliance

Microsoft Word

Windows environment

Independent work

Education

Bachelor’s degree in Chemistry

Tools

MasterControl

TrackWise

Job description

Cambrex is seeking an AD Technical Writer to generate high quality technical documents—test procedures, protocols, and reports—based on data from the Analytical Development department. Role requires adherence to SOPs, cGMP, ICH, and regulatory guidelines.

You will draft, review, and finalize controlled documents and coordinate approvals using MasterControl and TrackWise. Bachelor’s degree in Chemistry and 2+ years in a cGMP lab are preferred.