Eclaro
Quality - Technical writer Technical writer
Eclaro, Kingsgate, Washington, United States,
Technical Writer
Job Number: 24-03338
Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Technical Writer for our client in Bothell, WA.
ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview: The Manufacturing (MFG) Tech Writer supports the implementation of Enterprise Resource Programs for Manufacturing Operations at the Client Bothell site by managing document revision workflows, including the document change control process as well as review and approval of documents within the document management system.
Pay Rate: $55.00 - $58.00/Hour
Responsibilities: Support the implementation of the eMES Enterprise Resource Program and development and integration of Syncade MES at the Bothell site. 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.
Required Skills: Minimum of 1 year of relevant document management in a cGMP/FDA regulated environment. 1-2+ years of MS Office 365 1+ years working in quality systems or project work
Qualifications: Education: 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.
If hired, you will enjoy the following ECLARO Benefits: 401k Retirement Savings Plan administered by Merrill Lynch Commuter Check Pretax Commuter Benefits Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO
If interested, you may contact: Sofia Dela Torre Sofia.DelaTorre@eclaro.com (332) 206-0779
Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Technical Writer for our client in Bothell, WA.
ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview: The Manufacturing (MFG) Tech Writer supports the implementation of Enterprise Resource Programs for Manufacturing Operations at the Client Bothell site by managing document revision workflows, including the document change control process as well as review and approval of documents within the document management system.
Pay Rate: $55.00 - $58.00/Hour
Responsibilities: Support the implementation of the eMES Enterprise Resource Program and development and integration of Syncade MES at the Bothell site. 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.
Required Skills: Minimum of 1 year of relevant document management in a cGMP/FDA regulated environment. 1-2+ years of MS Office 365 1+ years working in quality systems or project work
Qualifications: Education: 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.
If hired, you will enjoy the following ECLARO Benefits: 401k Retirement Savings Plan administered by Merrill Lynch Commuter Check Pretax Commuter Benefits Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO
If interested, you may contact: Sofia Dela Torre Sofia.DelaTorre@eclaro.com (332) 206-0779
Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.