Analytical Development Technical Writer

Job Overview

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

• 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 Master Control and Track Wise.
• 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.

All employees are required to adhere to EPA, DEA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section, may be assigned.

• 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.

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

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, which may include 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.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity/affirmative 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.