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Documentation Specialist
Documentation SpecialistTekWissen LLC • Bend, Oregon, USA
Documentation Specialist

Documentation Specialist

TekWissen LLC • Bend, Oregon, USA
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Overview :

TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing scientific expertise and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients Bioscience Biopharmaceuticals Custom manufacturing Biotechnology Life science ingredients Nutrition Microbial Control Agriculture Materials Science Personal Care and cell and gene therapy.

Job Title : Documentation Specialist / QA Documentation Specialist I

Location : Bend OR

Duration : 6 Months

Job Type : Temporary Assignment

Work Type : Onsite

Shift Days : Monday to Friday

Summary

The role involves supporting the implementation and continuous improvement of Quality Systems in compliance with GMP regulations. It includes managing controlled records and documents maintaining proper documentation processes and assisting in audit activities to ensure regulatory compliance.

Key Responsibilities

  • Continuously develop and maintain knowledge of GMP regulations.
  • Support implementation and continuous improvement of Quality Systems.
  • Manage record control including receipt reconciliation scanning verification check-in / check-out and maintaining scanned backups.
  • Issue and track controlled documents and numbering.
  • Support internal and external audit activities.
  • Perform additional duties as assigned.

Level of Authority

  • Accountable for accuracy of assigned work.
  • Provides guidance on GMP practices and procedures.
  • Required Skills

  • High School Diploma or GED required.
  • Prior experience working in a GMP-regulated or quality-driven environment.
  • Basic understanding of audit processes and regulatory documentation requirements.
  • Familiarity with document control systems or electronic quality management systems (eQMS).
  • Strong attention to detail.
  • Excellent oral and written communication skills.
  • Proficiency in Microsoft Word and Excel.
  • Self-motivated with a positive attitude.
  • Ability to collaborate effectively with cross-functional teams in a fast-paced environment.
  • TekWissen Group is an equal opportunity employer supporting workforce diversity.

    Key Skills

    Environment,Ado,Carpentry,Drafting,Front Office Management,Airlines

    Employment Type : Full Time

    Experience : years

    Vacancy : 1

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    Documentation Specialist • Bend, Oregon, USA

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