Technical Writer Apply
Immediate need for a talented Technical Writer. This is a 12+ Months Contract opportunity with long-term potential and is located in Bothell, WA(Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID: 24-05192
Pay Range: $48- $54/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key 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.
Key Requirements and Technology Experience:
- 1-2+ years managing GMP Documents.
- 1-2+ years of MS Office 365.
- 1+ years working in quality systems or project work.
- Bachelor s degree or equivalent combination of education and experience.
- Minimum of 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.
Our client is a leading Pharmaceutical Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
