Analytical Development Technical Writer

Cambrex - Charles City; Charles City (IA); On-site; USD 60,000 - 80,000; Full time

Job summary

Cambrex - Charles City is seeking an AD Technical Writer to generate high quality technical documents such as test procedures, protocols, and reports based on data from the Analytical Development group. The role requires adherence to cGMP, EPA, FDA and other regulatory guidelines.

Responsibilities include drafting, revising, and approving documents using MasterControl and TrackWise, compiling data from notebooks and instruments, and collaborating with AD, QC, and QA to meet evolving business

Qualifications

• Drafting and revising controlled documents such as test procedures, protocols, reports, and SOPs.
• Coordinate the approvals of documents using MasterControl and TrackWise.
• Compile data from laboratory notebooks and instrumentation software for reports.

Responsibilities

• Draft and revise controlled documents following guidelines for correctness, completeness, clarity, and format.
• Coordinate approvals through MasterControl and TrackWise.
• Compile and present data from multiple sources.
• Maintain communication with AD, QC, and QA to ensure timely delivery of high quality documents.
• Improve documentation systems to increase efficiency and compliance.

Skills

Technical writing

Regulatory knowledge

Education

Bachelor’s degree in Chemistry or related field

Tools

MasterControl

TrackWise

Job description

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 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.

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.

Qualifications

• 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.

Equal employment opportunity, including veterans and individuals with disabilities.