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Cambrex High Point Analytical Technical Writer in Charles City, Iowa

Overview

  • GENEROUS RELOCATION ASSISTANCE!!

  • #1 small molecule API Contract Manufacturing Organization (CMO) in the USA

  • Double digit sales growth each of the last 5 years

  • Recent $75 million expansion of our large-scale API facility

  • Winner of 30 CMO Leadership Awards in 2017

  • IOWA – Ranked #1 state for best place to live by US News and World Report

  • Leading Western supplier of generic APIs including ADHD and other controlled substances

TheAnalytical Technical Writerwill 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

  • Bachelors degree in Chemistry or closely related field required.

  • Minimum of 2 or more years of experience in a cGMP regulated laboratory environment highly preferred.

  • 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.

    Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. (https://careers-cambrex.icims.com/jobs/1645/analytical-technical-writer/job?mode=apply&apply=yes&in_iframe=1&hashed=-336240429)

Job LocationUS-IA-Charles City

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