Analytical Development Technical Writer

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

Job Overview

The AD Technical Writer will consistently generate high quality technical documents, such as test procedures, protocols, and reports based on data collected by other members of the Analytical Development department that meet the needs of other departments, clients, and regulators. Compliance with SOPs, cGMP, ICH, and other regulatory guidelines is required to perform most job tasks.

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.

Qualifications / Skills

• 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.

Education, Experience & Licensing Requirements

• Bachelor’s degree in Chemistry or closely related field required.
• Minimum of 2 or more years of experience in a cGMP regulated laboratory environment highly preferred.

Pre‑employment Screening

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre‑employment screen. The pre‑employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.

Equal Opportunity

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affidavit Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.