Document Control Specialist

Dexian; Fremont (CA); On-site; USD 57,859 - 59,236; Part time

Job summary

A technology services company seeks an R&D, Technical Writing Analyst in Fremont, CA. The role involves creating regulatory complaint product labeling, engaging in new product development, and ensuring compliance through documentation. Candidates should possess a Bachelor’s Degree in Graphics or Language and proficiency in Microsoft and Adobe applications. This contract position offers a pay rate of $42-43/hr, requiring strong attention to detail and management of a varied workload.

Qualifications

• Bachelor’s Degree in Graphics or Language or equivalent experience.
• High level of service and responsibility in managing a high and varied workload.
• Proficiency in Microsoft applications (Word, Excel, PowerPoint, and Visio).
• Proficiency in Adobe Suite (InDesign, Photoshop, and Illustrator).

Responsibilities

• Create end‑user regulatory complaint product labeling.
• Contribute to new product development and design change.
• Engage with cross‑functional teams to resolve obstacles.
• Prepare for internal and external audits and maintain compliance.

Skills

Proficiency in Microsoft applications

Proficiency in Adobe Suite

High level of service and responsibility

Demonstrated application using database‑driven labeling system

Education

Bachelor’s Degree in Graphics or Language

Job description

Job Title: R&D, Technical Writing Analyst

Location: Fremont, CA

Pay Rate: $42-43/hr (on W2)

Base Pay Range: $42.00/hr - $43.00/hr

Employment Type: Contract

Responsibilities

• Responsible for creating end‑user regulatory complaint product labeling that will support business requirements.
• The specialist may contribute to new product development and design change (sustaining) activities in the areas of label design/release, development of artwork/images and development or improvement of processes for improved efficiency and compliance.
• This role will engage with and mobilize 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.
• Researches and builds knowledge about products, service, technology, test method and documents in the clearest, most logical way for greatest reader comprehension.
• Drives continuous improvement (NCs and CAPAs) and assessment of current procedures, generation of quality plans and identification of best practices.
• Prepares for internal and external audits by gathering records, supporting backroom, and providing explanation for design areas developed by self with auditor in the Front Room.
• Fully supports the Quality Policy by building quality into all aspects by maintaining compliance to all quality requirements and supporting improvements that make it easier for the organization to maintain compliance in complex areas.
• Demonstrates extensive application of knowledge through delivery of high‑quality deliverables (SOPs, technical literature and Work Instructions, engineering work product) to ensure continuity of content style that meets applicable standards and is appropriate for its intended audience.
• Maintains strong attention to detail, reviews and audits other technical publications deliverables and consistently delivers quality documentation with no escapes.
• Executes the creation/refinement of department and quality system SOPs, Work Instructions, forms, and templates that have considerable graphical content with minimal supervision, as regulations change and quality systems are merged/aligned.
• Provides input to creation of training and communication materials that can be used by self or other staff to convey new or updated processes.
• Has experience in modifying existing and creating new Quality System documentation (work instructions, standing operating procedures, forms, checklists, and templates).
• Leads structured problem‑solving initiatives to resolve complex technical issues and documents within appropriate quality system documentation.

Qualifications

• Bachelor’s Degree in Graphics or Language or equivalent experience (Advanced degree may be considered toward years of experience).
• High level of service and responsibility in managing a high and varied workload from internal customers and is comfortable working to tight timelines.
• Provides weekly summary of activities, creates project plans, prioritizes, and effectively communicates updates to customers.
• Follows Good Document Practices (GDP) for all documentation created/reviewed and stays current on all required training for incumbent position.
• Proficiency in Microsoft applications (Word, Excel, PowerPoint, and Visio).
• Proficiency in Adobe Suite (InDesign, Photoshop, and Illustrator).
• Demonstrated application using database‑driven labeling system such as Prisym ID, Label View, Loftware, Bartender, Nice Label, and/or Easy Label.
• Supports IFU development and release in PLM for new product development and design changes in conjunction with product labeling to ensure congruency with strong attention to detail.
• Manages tasks related to IFU/Literature printing suppliers and translation supplier.

Equal Opportunity Employer: Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.