Technical Writer

Company: TALENT Software Services
Location: Novato
Posted on: November 20, 2022

Job Description:

Are you an experienced Technical Writer with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Technical Writer to work at their company in Novato, CA.
Position Summary: The QC Analytical Technical Writer is accountable for technical writing projects supporting Central QC functions, including but not limited to generating reference material qualification protocols and reports, undertaking statistical analysis of data to support generation of process trends and control limits and reference material/ product acceptance ranges. The individual prepares trend graphs and analyses, and compiles results into technical documentations intended for internal use and direct submission to involved regulatory agencies. The scope of the position covers both clinical and commercial programs across multiple therapeutic platforms. The individual is responsible for ensuring that functional objectives are aligned with company goals and multi-national regulations. The individual interfaces with QC Product Coordination, QC testing groups (QC Product, QC Analytical, QC In-process, both Novato and Shanbally locations), Analytical Sciences, Process Development, MSAT, QA, and Regulatory Affairs to ensure accurate, comprehensive, and timely completion of documentation. The position required practical access, practical knowledge, and use of LIMS and Trackwise (Quality Events, Deviations, CAPAs, LIR, Change Request). The individual possesses or can rapidly develop skills in data trending software (JMP, Discoverant) and Statistical Process Control (SPC) charts. Strong interpersonal skills are required to interact with multiple cross-disciplinary departments and effectively function as a member of teams. Ability to train staff at all levels in use of software and data trending procedures is required. The individual performs duties with a high degree of independence and minimal supervision.
Primary Responsibilities/Accountabilities:

• Prepares technical documentation intended for internal use and for direct submission to involved regulatory agencies.
• Initiates and completes Quality System processes in Trackwise
• Directly accesses data from LIMS
• Undertakes data analysis in data trending software to generate and support conclusions in technical documentation
• Supports development of data trending tools for hands-on use by the Quality organization (e.g., QC Site Testing groups in Novato and Shanbally) by testing enhanced systems, preparing work instructions, and training personnel.
• Works with ambiguity and complexity to continuously optimize options and solutions
• Applies sound problem-solving skills to recommend options and implement effective solutions
• Other duties as assigned

Keywords: TALENT Software Services, Novato , Technical Writer, Engineering , Novato, California