Labelling and Documentation Specialist

2 weeks ago

Fremont, United States Comrise Full time

Labelling and Documentation Specialist - 12 month contract - Fremont, CA

Opportunity with a leading Medical Device company


As part of Sustaining R&D, the Lead Analyst, R&D Technical Writing is responsible for creating end-user regulatory complaint product labeling. The specialist contributes to new product development and design change (sustaining) activities in the areas of labeling design/release, technical writing, translation management, development of artwork/images and development or improvement of processes for improved efficiency and compliance. This role will engage with cross functional teams to resolve obstacles effectively, be responsible for meeting key labeling objectives, and lead/collaborate on continuous improvement initiatives or special activities having business impact.


General Requirements:

• 4-6 years of relevant experience in developing or delivery of technical publications that are part of products including writing, graphic design, development of artwork/images, document control, related to engineering, with part of experience in a medical device/regulated industry:

• Bachelor’s Degree in Graphics or Language or equivalent experience (Advanced degree may be considered towards years of experience)

• Required to have a high level of service and responsibility in managing highly detailed and varied workload from internal customers and be comfortable working to tight timelines

• Provide weekly summary of activities, create project plans, prioritize, and effectively communicate updates to customers

• Follow Good Document practices (GDP) for all documentation created/reviewed and staying current on all required training for incumbent position

• Subject Matter Expert (SME) in Microsoft Applications (Word, Excel, PowerPoint, and Visio), Adobe Suite (InDesign, FrameMaker, Photoshop, and Illustrator)

• Demonstrated experience in the following: Instructions for Use, Training Guides, Support of Electronic IFU (eIFU) and website, Translation management

Required Software:

• Microsoft applications (Word, Excel, PowerPoint, and Visio)

• Adobe Suite (InDesign, Frame Maker, Photo Shop, and Illustrator)

• Experience in website design and testing

Nice to have Software:

• For Label Designer Role: Database driven labeling system such as Prisym ID, Label View, Loftware, Bartender Nice Label, and Easy Label, Computer Aided Drafting (CAD) – Solidworks, AutoCAD

  • Quality & Documentation Specialist

    4 weeks ago

    Fremont, United States Bay Area Circuits Inc Full time

    Job DescriptionJob DescriptionCompany Overview:Bay Area Circuits has served the Printed Circuit Board needs of high-tech electronics manufacturers, contract assemblers, and design engineers for over 40 years. Bay Area Circuits has become the premiere PCB supplier for discerning customers worldwide by focusing on quick-turn prototyping and production while...

  • Documentation Specialist

    1 week ago

    Fremont, United States eTeam Full time

    Job Title: Documentation specialist III - AutoCADLocation: Fremont, CA (Remote)Duration: 6 monthsMust have skills:Expert knowledge in AutoCAD and designSite facility knowledgeExperience in GMP manufacturing facilitiesAn ability to read, understand and modify Engineering drawings, including P&ID’sWork hoursCollaborative work must be performed in Pacific...

  • Documentation Specialist

    7 days ago

    Fremont, United States eTeam Full time

    Job Title: Documentation specialist III - AutoCADLocation: Fremont, CA (Remote)Duration: 6 monthsMust have skills:Expert knowledge in AutoCAD and designSite facility knowledgeExperience in GMP manufacturing facilitiesAn ability to read, understand and modify Engineering drawings, including P&ID’sWork hoursCollaborative work must be performed in Pacific...

  • Documentation Specialist I

    1 month ago

    Fremont, United States Fladger Assoc. Inc. Full time

    Job DescriptionJob DescriptionFremont, CAContract Duration: 5-24 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Documentation Specialist I in the Fremont, CA area. This position leads all paper/electronic batch record review that is related to manufacturing of drug substance in a multi-product facility. The position performs...

  • Document Control Specialist

    3 days ago

    Fremont, United States Aehr Test Systems Full time

    **Aehr Test Systems** (NASDAQ: AEHR) is a market leader in the Semiconductor Capital Equipment Industry, providing advanced solutions for semiconductor Burn-In and Test for EV market. Our innovative single touchdown full wafer burn-in and massively parallel test systems are revolutionizing the power semiconductor industry. Come join our team! We are seeking...

  • Documentation Specialist III

    5 days ago

    Fremont, United States Compunnel Inc. Full time

    Documentation Specialist III / AutoCADDuties:The US Biopharma E&T (Engineering & Technology) Department is seeking a service partner to support revisions to our Facility and Engineering Drawings and Documentation database.These drawings are very critical to the site for design and maintenance activities.The drawings are maintained electronically in our CAD...

  • Documentation Specialist III

    4 days ago

    Fremont, United States Compunnel Inc. Full time

    Documentation Specialist III / AutoCADDuties:The US Biopharma E&T (Engineering & Technology) Department is seeking a service partner to support revisions to our Facility and Engineering Drawings and Documentation database.These drawings are very critical to the site for design and maintenance activities.The drawings are maintained electronically in our CAD...

  • Documentation Specialist III

    6 days ago

    Fremont, United States Compunnel Inc. Full time

    Documentation Specialist III / AutoCADDuties:The US Biopharma E&T (Engineering & Technology) Department is seeking a service partner to support revisions to our Facility and Engineering Drawings and Documentation database.These drawings are very critical to the site for design and maintenance activities.The drawings are maintained electronically in our CAD...

  • Document Control Specialist

    3 days ago

    Fremont, United States Aehr Test Systems Full time

    Job DescriptionJob DescriptionSalary: $105-$120KAehr Test Systems (NASDAQ: AEHR) is a market leader in the Semiconductor Capital Equipment Industry, providing advanced solutions for semiconductor Burn-In and Test for EV market. Our innovative single touchdown full wafer burn-in and massively parallel test systems are revolutionizing the power semiconductor...

  • Documentation Specialist III

    4 days ago

    Fremont, United States MRS Full time

    Job DescriptionJob DescriptionJob Title: Documentation Specialist IIILocation: Fremont CA 94555Duration: 7 MonthsJob Description:1st Shift: Mon-Fri, 8AM-5PMDuties:    The US Biopharma E&T (Engineering & Technology) Department is seeking a service partner to support revisions to our Facility and Engineering Drawings and Documentation database. These...

  • Document Specialist

    2 days ago

    Fremont, United States Ryzen Solution Full time

    **Position Summary**: ECS is a Documentation and Change Order (ECR/ECO) specialist responsible for engineering change control process as part of PLM. Beyond generating and processing Change Orders, duties will include data mining, POC for change related escalations, managing trackers, inter department reports and CIP activities in a high pace...

  • Senior Technical Publications Specialist

    2 days ago

    Fremont, United States JBL Resources Full time

    The Senior Technical Publications Specialist will be responsible for creating end-user regulatory complaint product labeling that will support the EU MDR product.Accepting no less than the absolute best, our Client has climbed to the top, gaining a reputation for both excellence and satisfaction. Working at this company will give you the opportunity to work...

  • Senior Technical Publications Specialist

    3 weeks ago

    Fremont, United States JBL Resources Full time

    The Senior Technical Publications Specialist will be responsible for creating end-user regulatory complaint product labeling that will support the EU MDR product.Accepting no less than the absolute best, our Client has climbed to the top, gaining a reputation for both excellence and satisfaction. Working at this company will give you the opportunity to work...

  • Documentation Specialist

    7 days ago

    Fremont, United States Aequor Full time

    Documentation Specialist III Location: Fremont, CA/Remote Duration: 6+ Months The US Biopharma E&T (Engineering & Technology) Department is seeking a service partner to support revisions to our Facility and Engineering Drawings and Documentation database. These drawings are very critical to the site for design and maintenance activities. The drawings are...

  • Documentation Specialist

    1 week ago

    Fremont, United States Aequor Full time

    Documentation Specialist III Location: Fremont, CA/Remote Duration: 6+ Months The US Biopharma E&T (Engineering & Technology) Department is seeking a service partner to support revisions to our Facility and Engineering Drawings and Documentation database. These drawings are very critical to the site for design and maintenance activities. The drawings are...

  • Documentation Specialist

    7 days ago

    Fremont, United States Aequor Inc Full time

    Documentation Specialist III Location: Fremont, CA/Remote Duration: 6+ Months The US Biopharma E&T (Engineering & Technology) Department is seeking a service partner to support revisions to our Facility and Engineering Drawings and Documentation database. These drawings are very critical to the site for design and maintenance activities. The drawings are...

  • Documentation Specialist III

    7 days ago

    Fremont, United States Mindlance Full time

    Duties: The US Biopharma E&T (Engineering & Technology) Department is seeking a service partner to support revisions to our Facility and Engineering Drawings and Documentation database. These drawings are very critical to the site for design and maintenance activities. The drawings are maintained electronically in our CAD (Computer Aided Design) database....

  • Documentation Specialist Iii

    1 week ago

    Fremont, United States Boehringer Ingelheim Full time

    **Summary**: The US Biopharma E&T (Engineering & Technology) Department is seeking a service partner to support revisions to our Facility and Engineering Drawings and Documentation database. These drawings are very critical to the site for design and maintenance activities. The drawings are maintained electronically in our CAD (Computer Aided Design)...

  • Image Transaction Specialist

    15 hours ago

    Fremont, United States Western & Southern Mutual Holding Company, Inc. Full time

    Scans and indexes paper documents into the imaging system to trigger workflows for further electronic processing throughout the organization. Prioritizes imaging functions to fulfill requests in a timely and quality manner. All documents are to be ha Specialist, Transaction, Processing, Insurance, Healthcare, Training

  • Contract Specialist, GS-1102-12

    3 days ago

    Fremont, California, United States U.S. Coast Guard Full time

    This position serves as a Contract Specialist and is responsible to provide procurement supposrt for Coast Guard units nationwide and Coast deployed units worldwide. Complete responsibility to plan and recommend for execution, all contractal actions and phases for assigned programs.Being a Coast Guard civilian makes you a valuable member of the Coast Guard...