Analytical Development Technical Writer

Cambrex; Charles City (IA); On-site; USD 60,000 - 90,000; Full time

Job summary

Cambrex is seeking an AD Technical Writer to generate high quality technical documents—test procedures, protocols, and reports—based on data from the Analytical Development department. Role requires adherence to SOPs, cGMP, ICH, and regulatory guidelines.

You will draft, review, and finalize controlled documents and coordinate approvals using MasterControl and TrackWise. Bachelor’s degree in Chemistry and 2+ years in a cGMP lab are preferred.

Qualifications

• 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.

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.

Skills

Advanced technical writing

Fluent English

cGMP compliance

Microsoft Word

Windows environment

Independent work

Education

Bachelor’s degree in Chemistry

Tools

MasterControl

TrackWise

Job description

You Matter to Cambrex.

You Matter to Cambrex.

Company Information
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.
With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.
Your Work Matters.

Your Work Matters.

• engage in work that matters to our customers and the patients they serve
• learn new skills and enjoy new experiences in an engaging and safe environment
• strengthen connections with coworkers and the community

We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!

Your Future Matters.

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world.

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 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/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.

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.

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