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Quality Specialist II

Company: Katalyst Healthcares & Life Sciences
Location: Wilson
Posted on: January 22, 2023

Job Description:

Responsibilities:


  • Perform sampling, and inspection on incoming commercial and experimental/clinical raw materials, components, and intermediates.
  • Perform raw material component review to ensure correct quantities, labeling and visual appearance.
  • Oversee the administration of prompt event evaluation, investigation, closure and follow-up of process/equipment discrepancies and related areas as well as identify opportunities for continuous process improvements.
  • Comprehend and adhere to all related SOPs, company policies, cGxPs, and regulatory requirements.
  • Comprehend and adhere to all pertinent Health and Safety regulations, policies and procedures and the required use of all approved and issued Personal Protective Equipment.
  • Execute activities/tasks (i.e., sampling, cleaning, packaging component testing.) in accordance with approved SOPs, schedules and communicates expected processing times for incoming raw materials, components, and intermediates to appropriate Warehousing, Planning, Operations, Pharm Tech, and Quality management. Efficient and proactive in executing assigned activities.
  • Maintain current training status and close all training gaps in a timely fashion.
  • Prepare and maintain tracking/testing systems, (i.e., LIMS, SAP, Logbooks, OCR, etc.) which are used for testing and to reflect status of samples. Reports status to appropriate laboratory, manufacturing and planning groups at pre-determined intervals.
  • Provide timely day-to-day decisions on compliance related issues in Production, Warehouse/Distribution, Facilities, Incoming QA, Quality Control and Stability areas based on expertise and collection of independently gathered information.
  • Assess accuracy and compliance of plant SOPs as a SOP reviewer and approver and works with SOP author for timely approvals.
  • Communicate daily with supervision and others within work group as related to specific job function and demonstrate the ability to communicate with others outside of work group.
  • Demonstrate a level of consciousness to safety and health related activities as evident by the daily application of requirements specific to job function; Recognize safety and health related issues and report to supervision.
  • Support and maintain an environment that fosters communication and teamwork within Quality Assurance and related departments.
  • Perform other related assignments and duties as required and assigned.

    Requirements:


    • Basic understanding of applicable regulatory requirements as it relates to job function demonstrated by adherence to policies and procedures.
    • Basic ability to perform computer transactions related to job functions demonstrated by right first-time measures.
    • Ability to perform job function using appropriate instrumentation and applicable techniques demonstrated by efficient and accurate completion of work.
    • Ability to apply technical knowledge and experience in performing job functions as is displayed through independence in daily performance of work.
    • Ability to apply and evaluate systems and procedures for improvement opportunities demonstrated through discussion of recommendations with supervision.
    • Ability to overcomes obstacles to achieve results as indicated by ability to resolve issues and meet timelines.
    • Demonstrate application of industry best practices and specific regulatory requirements for evaluation of systems and procedures for improvement opportunities and communicates results and ideas to supervision on a regular basis.
    • Ability to troubleshoots and recommend improved methods or techniques of performing job function or utilizing instrumentation demonstrated by ability to achieve results, gain right first-time output, and improve efficiency.
    • Ability to utilize multiple IT systems required for job performance and utilize reports for analysis demonstrated by consistent right first-time results and independent resolution of issues
    • Recommend solutions to issues related to the job function in a timely manner.
    • Troubleshoot and provide immediate solutions for issues related to job function.
    • Execute corrective actions to prevent reoccurring problems.
    • Demonstrate ability to communicate with others outside of work group as related to the specific job function.
    • Contribute to functional areas outside of work group contributing expertise as related to the specific job function.

Keywords: Katalyst Healthcares & Life Sciences, Wilson , Quality Specialist II, Professions , Wilson, North Carolina

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