Analytical Technical Writer - Pharmaceuticals
Posted on: September 4, 2021
The Analytical 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
All employees are required to adhere to EPA, DEA, FDA, and cGMP
regulations related to the Company; and to adhere to all client's
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
- 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
- Maintain open communication with AD, QC, and QA members 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
- Bachelor’s degree in Chemistry or closely related field
- Minimum of 2 or more years of experience in a cGMP regulated
laboratory environment is highly preferred.
- Advanced technical writing skills and the ability to
communicate effectively with peers, department management, and
- Fluent in written English.
- Familiarity with compliance requirements within cGMP with an
emphasis on method validation and reporting requirements
- Demonstrated excellence in advanced word processing using
- 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
The client offers an extraordinary opportunity, a competitive
salary, and an exceptional benefits package including medical,
dental, vision care and prescription, life, LTD, STD; 401(k) with
employer match; tuition reimbursement; and the ‘Arthur I. Mendolia
Scholarship Program.’ Relocation assistance will be offered for
Keywords: Bevov, Waterloo , Analytical Technical Writer - Pharmaceuticals, Other , Waterloo, Iowa
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