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Technical Writer -Investigation/Deviation

Company: Integrated Resources, Inc ( IRI )
Location: Thousand Oaks
Posted on: August 3, 2022

Job Description:

  • The Compliance Investigator conducts root cause investigations, closes deviations, supports assignment of proper corrective actions, and facilitates implementation for Manufacturing under the direction of Compliance Management.
  • The position will conduct root cause investigations, close deviations, support assignment of proper corrective actions, and facilitate implementation for Manufacturing under the direction of Compliance Management.
  • Perform calculation, data collection in support of QC lab site, global CI initiatives, and management reviews. Participate in the development and technical writing of documentation for the validation of equipment and required to support testing of the Thousand Oaks Manufacturing Facility. Lead and/or drive completion of Lean or Six Sigma improvement projects and responsible milestones, as assigned. May function as a backup Supervisor. Ensure that the daily operations of assigned functional area are met through scheduling, troubleshooting and coaching.Primary Duties:-Populate Graphs-Translate Data into a technical report-Supports Compliance and Manufacturing-Write Investigations and DeviationsMust Haves:-Write Investigations and Deviations-Pharma Background Strongly Preferred-Regulatory Experience within Technical Writing Strongly PreferredResponsibilities:--- Support and/or lead continuous improvement projects such as Yellow Belt, Green Belt, 5S, Kaizen, Just-do-it's, VIPs using Lean/DMAIC concepts and philosophy.--- Assist Compliance Supervisor in leading daily operations to ensure coordination and efficiency.--- Participate in the generation of test plans, protocols, and reporting documentation for the validation of equipment supporting testing of the TO Facility.--- Perform review of test data with application of GDP.--- Use Global LIMS or other computerized systems for entering, approving, and trending test results.--- May be required to conduct investigations and/or audits into Alert/OOL excursions.--- Actively contribute to a team setting at the Thousand Oaks Manufacturing Facility and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support, as needed.--- Provide training and work direction for assigned functional areas.--- Investigate deviations and write exception documents as required, utilizing problem-solving tools as needed.--- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations.--- May be required to generate, execute, and/or summarize studies and/or review/revise of SOPs. Complete and/or direct completion of special project/protocol testing in a timely manner.--- Assist Compliance Supervisor in updating department metrics and report shift activities, as assigned.--- Ensure personal training requirements are met and that training records are current.--- May perform disposal of hazardous waste.--- Write and manage deviations (CAPA investigations, UIs, ICARs, OOXs, containment and/or corrective actions) under the direction of Compliance Management.--- Lead and/or facilitate problem solving events. Lead the investigation closure of manufacturing compliance related documents. Using quality and statistical tools to identify and implement proper corrective and preventative actions to manufacturing non-compliance.Education:Typically requires bachelor's degree in chemistry, biological science, or other related technical field. 2+ years of related experience.System Experience:-Trackwise (Strongly Preferred)-MS Office Suite Required

Keywords: Integrated Resources, Inc ( IRI ), Thousand Oaks , Technical Writer -Investigation/Deviation, Advertising , Thousand Oaks, California

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