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Technical Writer

Employer
Forge Biologics
Location
Columbus, Ohio
Start date
May 22, 2022

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Discipline
Clinical, Clinical Documentation
Required Education
Associate Degree
Position Type
Full time
Hotbed
BioMidwest
Role Description:

We are currently seeking a Technical Writer to join the Forge Biologics team. This is an exciting opportunity to drive the startup efforts by authoring, reviewing, and processing documents needed for our Columbus, Ohio operations. The candidate will collaborate with site Subject Matter Experts (SMEs) to transcribe process, procedure and work instructions into usable documents that will support our Quality Control (QC) and Analytical Development (AD) Management teams and adhere to cGMP principles. The ideal candidate will be skilled in technical writing, understand and learn new processes and methods quickly, as well as write and translate various subject matters clearly and in a concise manner that will support our employee training efforts.

The Technical Writer is responsible for authoring documents in support of Quality Control and Analytical Development teams at the Columbus facility. The Technical Writer will also support all new documents that may be deemed necessary as business requires. This role reports to the Senior Director of Quality Control but will also have indirect reporting to the Senior Director of Analytical Development.

 

Responsibilities:

  • Perform tasks such as creation of SOPs, Protocols, Reports, Methods, Training documents, Test Forms, etc. for QC and AD teams.
  • Participate in the development and timely update/revision of Quality Documents, work instructions, business process descriptions and templates relating to QC or AD.
  • Set up cross-functional reviews for all documents for which Tech Writer is responsible.
  • Organizes material according to set standards regarding order, clarity, conciseness, style, and terminology.
  • Edits, standardizes, or suggests changes to material prepared by other writers or Forge personnel to verify accuracy, consistency, grammar, and format.
  • Support Additional Technical writing functions as deemed necessary by the management in line with the new projects.
  • Other duties, as assigned.

 

Requirements:

  • Bachelor’s Degree, preferably in a Life Sciences or Engineering field (or equivalent work experience and education with an Associate Degree). (Equivalency is defined as a minimum of a 2-year Associate's Degree in addition to 2 years of experience in a Quality area or technical role drafting SOPs, scientific, and/or technical documents.)
  • Minimum of 2 years of experience in technical writing within a Biopharmaceutical/Pharma manufacturing/CDMO industry in Quality, Quality Control, or Analytical area (preferably in a GMP setting).
  • Must be self-motivated, organized, and proactive, with a strong attention to detail.
  • Intermediate to advanced computer software skills including Microsoft Office, database and spreadsheet creation and maintenance, as well as strong filing, organization, record keeping and planning, managing multiple projects, and time management skills.
  • Demonstrated experience authoring Standard Operating Procedures, Protocols, and Reports. Experience using advanced formatting tools in MS Word (specifically document formatting and/or correction using Microsoft Word styles and templates), PowerPoint and Microsoft Excel formats.
  • Experience with Veeva Vault, TrackWise, or equivalent document management software preferred and Adobe Acrobat PDF/DC experience is strongly desired.
  • Ability to work hours necessary to support critical and time sensitive activities.
  • Knowledgeable in FDA GMPs (21 CFRs 210, 211, and/or 600), GLP, and/or GDP a plus.
  • Demonstrated success working cross-functionally in a self-directed, onsite, and remote working environment.
  • In our commitment to safety of our employees and customers a COVID vaccination is required.

Reporting Outline:

  • This position reports to the Senior Director of Quality Control.
  • This position is based, onsite, in Grove City, OH.
  • Travel on an infrequent basis is required (<5%) to support job responsibilities and commitments.

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