Analytical Development Technical Writer – Regulatory Docs

Cambrex Corp.; Charles City (IA); On-site; USD 65,000 - 85,000; Full time

Job summary

Cambrex Corp. in Iowa is seeking an AD Technical Writer to produce high quality test procedures, protocols, and reports drawn from data across the Analytical Development department.

You will ensure compliance with SOPs, cGMP, ICH and other guidelines, coordinating with QA, QC, and other teams to meet regulatory needs. Responsibilities include drafting and revising controlled documents, managing approvals in MasterControl and TrackWise, and maintaining data from notebooks and instrument software.

Qualifications

• Bachelor's degree in Chemistry or related field required.
• At least 2 years in a cGMP laboratory environment preferred.
• Excellent technical writing and data interpretation skills.
• Experience with regulated document control systems is a plus.

Responsibilities

• Draft and revise controlled documents (test procedures, protocols, reports, SOPs) per guidelines.
• Coordinate document approvals using MasterControl and TrackWise.
• Compile data from lab notebooks and instrumentation software.
• Maintain communication with AD, QC, and QA to ensure timely delivery.
• Improve documentation systems to comply with cGMP requirements.

Skills

Technical writing

English proficiency

cGMP compliance

MS Word

Windows

Self-directed

Education

Chemistry degree

Tools

MasterControl

TrackWise

Job description

Cambrex Corp. in Iowa is seeking an AD Technical Writer to produce high quality test procedures, protocols, and reports drawn from data across the Analytical Development department.

You will ensure compliance with SOPs, cGMP, ICH and other guidelines, coordinating with QA, QC, and other teams to meet regulatory needs. Responsibilities include drafting and revising controlled documents, managing approvals in MasterControl and TrackWise, and maintaining data from notebooks and instrument software.