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PDS Tech Inc Document Review Technician in Shawnee Mission, Kansas

PDS Tech is seeking candidates for a Document Review Technician in Lenexa, KS

The Product Disposition Technician – QA (Document Review Technician) is a vital member of a dynamic team responsible for dispositioning the extensive portfolio of manufactured products. Responsible for timely review/approval of manufacturing documentation to support a challenging production schedule.

Key Responsibilities:

  • Review of production, packaging/labeling and laboratory documents for final product release; review for accuracy and completion.

  • Disposition products in a timely manner.

  • Identifies, reports, and seeks correction for deviations or noted in the workplace in a timely and prompt manner.

  • Expedite documentation issues to ensure timely disposition of products.

  • Appropriately escalates any product issues to Quality and Production management teams.

  • Leads day-to-day activities to ensure swift and accurate completion of product disposition activities.

  • Maintains standards in accordance with cGMP's/SOP's and ISO regulations.

  • Supports tracking departmental metrics and meeting departmental goals.

  • Organizes records and supports archiving of records for end of the year fiiing

  • Manage a continuous improvement program within the Quality Assurance department.

  • Follows and supports all company policies.

  • Performs other duties as assigned.

Minimum Requirements/Qualifications:

  • Possess high school diploma or GED minimum, Associates degree preferred.

  • Course work in the sciences is a plus.

  • Document review experience is preferred.

  • Strong attention to detail and highly organized.

  • Possess proficient computer skills, preferably with experience in Word, Excel and SAP programs.

  • Excellent analytical, prioritization, multi-tasking, problem-solving, and communication skills.

  • Familiarity with FDA regulations for medical devices is a plus.

  • Must be able to communicate, both written and verbally, using the English language.

  • Must be able to comprehend and follow both written and/or verbal English communications.

  • Works well independently and within a team environment.

  • Must be able to lift up to 25 lbs (standard filing boxes

  • Must be able to stand and sit for long periods.

  • Must be able to walk to retrieve documents in areas where loud noises and strong smells are present

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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