Manufacturing Technical Writer

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500 employees globally, with over 30 locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants.

Company: One of Our Clients

Job Description:

Job Title: Manufacturing Technical Writer

Location: Bothell, WA 98021

Duration: 12 Months (Extendable)

Pay Rate: $54.00/hr on W2

TOP 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

Position Summary

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.

Primary responsibilities include:

• 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.

Education: Bachelor’s degree or equivalent combination of education and experience

Experience Basic Qualifications:

• 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.

Awards and Accolades:

• America's Most Honored Businesses (Top 10%)
• Awarded by USPAAC for Fastest Growing Business in the US
• 12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
• Fastest 50 by NJ Biz (2020, 2019, 2020)
• INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
• Top 100 by Dallas Business Journal (2020 and 2019)
• Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
• 2019 Spirit of Alliance Award by Agile1
• 2018 Best of the Best Platinum Award by Agile1
• 2018 TechServe Alliance Excellence Awards Winner
• 2017 Best of the Best Gold Award by Agile1(Act1 Group)

Regards,

Kajal Singh

Senior IT Recruiter (Pharma and Life Sciences)

Net2Source Inc.

Global HQ Address –270 Davidson Ave, Suite 704, Somerset, NJ 08873, USA

Office: (201) 340-8700 x 980 | Cell: (201) 777-4217 | Fax: (201) 221-8131| Email: singh.kajal@net2source.com