Analytical Development Technical Writer

Cambrex•Charles City, IA

15d•Onsite

About The Position

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 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.

Requirements

Advanced technical writing skills and the ability to communicate effectively with peers, department management, and cross-functional coworkers.
Fluent in written English.
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 closely related field required.
Minimum of 2 or more years of experience in a cGMP regulated laboratory environment highly preferred.

Nice To Haves

Familiarity with compliance requirements within cGMP with an emphasis on method validation and reporting requirements preferred.

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.
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.