Technical Writer (Pharma)

Technical Writer (Pharma) Job Summary:

A leading global contract development and manufacturing organization (CDMO) in St. Louis, MO is seeking a Technical Writer. This is a contract-to-hire role and it will require you to work onsite five days a week. As a Technical Writer, you will author new and revise existing documents to ensure content accuracy and conformance to established standards. The scope includes, but is not limited to, developing and/or revising standard operating procedures, batch records, forms, and training documents to support aseptic operations.

Technical Writer (Pharma) Responsibilities:

• Write standard operating procedures with appropriate details that are easily understood, readily usable for consistency in training, and conform to company policies and government regulations.
• Develop procedural documents using human performance and technical writing tools that enable right-first-time document execution efficiencies. Regularly monitors department documentation metrics for the purpose of making document improvements to minimize the potential for data entry errors on executable forms.
• Review and analyze new and existing procedures for concurrence with correct department methods through direct observation of aseptic manufacturing processes and interviews with subject matter experts.
• Manage department document projects; ensure project deliverables are completed per the project timeline.
• Draft new and revised SOPs, Batch Records, Forms, and OJT skill assessment documents.
• Leads continuous improvement efforts related to GMP documentation.
• Interact with internal departments to develop new and revised documents. Directly interact with the sites' Manufacturing, Quality, Validation, Regulatory and EHS Departments to ensure document revisions are accurate, executable and comprehendible.
• Track and report document status for key projects.

Technical Writer (Pharma) Qualifications:

• Associates degree in life science, education/training, or other equivalent related discipline.
• 1-2 years pharmaceutical experience.
• Excellent project management and organizational skills including the ability to independently understand, follow, and implement complex instructions and follow assignments through to completion.
• Knowledge of Quality Systems as it relates to GMP documentation requirements.
• Strong technical writing ability with experience writing instructional documents.
• Advanced computer skills that include MS Word, Visio, PowerPoint, Excel, Adobe Acrobat. Ability to work in and create Microsoft Word Templates. Ability to create and revise complex Word documents that include formatting pictures, tables, shapes, and embedded macros.
• Project management and organizational skills.
• Excellent verbal and written communication skills.
• Interpersonal and communication skills required to build and maintain working partnerships with all levels of the organization.

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This job is In-Person.

Pay Range: Hourly $26.00 to $28.00

We offer several comprehensive benefits package including health and life insurance, paid and unpaid time off, and retirement and savings plans to qualifying employees.

Download the Sparks Group mobile app from Apple App Store or Google Play.

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Sparks Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, pregnancy, citizenship, family status, genetic information, disability, or protect veteran status.