Job Listing Description

Technical Writer

Chipton-Ross is seeking a Technical Writer for an opening in Fremont, CA.

Technical Writer I is primarily responsible for supporting Manufacturing Services (Filling, Label Printing, & Packaging) by creating, editing, and maintaining manufacturing procedures. This role works cross-functionally with Quality and Operations teams to develop comprehensive procedures and documents that meet regulatory compliance requirements.

Work cross-functionally with other teams to create or revise manufacturing procedures via change control procedure. Work with department subject matter experts to improve documented processes. Help correct and document nonconformities when necessary. Develop, improve, implement, and validate manufacturing process within Filling, Packaging, and Labeling departments. Work closely with Process Validation and Quality Assurance teams to develop processes, procedures, and specifications. Responsible for reviewing quality requirements and documentation related to manufacturing processes to ensure quality products are delivered. Maintain strict compliance with ISO13485, cGMP, QSR and other applicable Quality Management System standards. Proof-read and provide feedback on documentation prepared by other departments. Assist with completion of CAPA investigations write-ups and action items Additional tasks as assigned. Review and recommends revisions or changes in scope, format, and content to existing documentation. Maintain records and files of work and revisions. Create part numbers and Bill of Materials into the Material Resource Planning (MRP) software as required. Organize large amounts of technical information utilizing Advanced MS Word and Excel functions as well as manage a large number of technical documents simultaneously. Technically strong to work independently and collaborate with cross functional teams to identify appropriate content updates as required. Participate in cross functional documentation projects as required. Standardize and streamlines documents and documentation system in coordination with technical personnel and managers. Keep department lead or manager updated on all issues.

Effective communication skills and the ability to collaborate with cross functional teams. Experience (minimum): 1-3 years medical device or pharmaceutical experience ISO 13485, FDA QSRs, GMP or IVDs. Ability to work independently with minimal guidance and as part of a team; establish priorities, manage multiple activities, and adjust to changing priorities in a dynamic, FDA regulated environment. Strong attention to detail, and a thorough understanding of technical terminology and complex manufacturing processes. Experience in using an electronic Document Management System as a Technical Writer. Must be computer literate and competent in PC based software such as Office 2010 Professional (Word, Excel, Access, and PowerPoint). Proficient with 55+ wpm minimum typing speed. Ability to work independently with minimal guidance and as part of a team; establish priorities, manage multiple activities, and adjust to changing priorities in a dynamic work environment. Must be organized and detail oriented to be able to prioritize own and otherís work and meet business productivity metrics. Proofreading and editing skills, and an aptitude for numbers and detail-oriented work requiring a high degree of accuracy. Must have excellent customer service and listening skills. Basic arithmetic skills including the ability to calculate figures and amounts and to interpret the data. Able to sit, stand and/or use keyboard for long periods of time. Ability to lift and/or move up to 20 lbs.

Accredited B.S./B.A. in science or related engineering discipline or technical field.

Shift: 8-5pm/ 40 hrs /week
Job Number: 195788
Job Location: Fremont, CA
Rate: Up to $25.00 DOE
Duration: 6 mos
Input Date: 11/17/2021
Attention: Leila Morrow
Address: 420 CULVER BLVD
City, State: PLAYA DEL REY, CA 90293
Phone: 310/414-7800 X286
800 Phone: 800/927-9318
Fax Phone: 310/414-7808

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