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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Technical writer

Job Description

  • Type: Contract
  • Job #78583

Our client, a leading pharmaceutical company, is hiring a Technical Writer on a contract basis.

Work Location:
Bothell, WA – 100% on site

Summary:
The Manufacturing (MFG) Tech Writer supports Manufacturing Operations by managing document revision workflows, including the document change control process as well as review and approval of documents within the document management system.

Knowledge/Skills Required/Education:

  • Bachelors degree or equivalent combination of education and experience.
  • 1 year of relevant document management in a cGMP/FDA regulated environment.
  • Strong communication and customer service skills.
  • Some technical writing skill set including the ability to critically review documents while effectively inputting and expressing Quality principles.
  • Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)
  • Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.
  • Able to prioritize, manage time well, multi-task, and troubleshoot effectively.
  • Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
  • Possess project management skills.
  • Experience interacting with FDA or other regulatory agencies preferred.
  • Knowledge of cGMPs and regulatory requirements.
  • Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).
  • Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network.

Responsibilities:

  • Managing document revision workflows in an electronic document management system for Manufacturing, which includes reviewing and approving document change requests, editing documents and incorporating SME input.
  • May own and revise Manufacturing procedures including participating on project teams as a key stakeholder.
  • Collaborate with Quality Systems record owners to complete change and CAPA action deliverables.
  • Follow Policies, SOPs, and work instructions to support the document revision process.
  • Track in flight document workflows and provide status updates as required.
  • Support internal and external audits and regulatory inspections if required. Assist with document retrieval /organization support during regulatory inspections.
  • Provide communication as to the status of Quality Systems deliverables to customers, management, and stakeholders.
Pay Range: $54-$55/hr
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