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GxP Documentation Specialist

Indianapolis 26 - 30 DOE p/h Contract

Job Responsibilities:

  • Utilize technical writing strategies to ensure clarity, conciseness, and completeness of documentation.
  • Author and revise technical documentation, including facility and equipment SOPs, batch records, specifications, and training documents.
  • Manage change controls to implement new procedures and revisions to documentation and SOPs.
  • Participate in process and equipment testing, gaining a comprehensive understanding of systems being documented.
  • Complete deviations, CAPAs, change controls, document revisions, and training activities to meet quality system requirements and timelines.
  • Collaborate with operations, R&D, and quality representatives to fulfill all project documentation requirements.


Qualifications:

  • Bachelor's degree in Chemistry, Biology, Microbiology, Engineering, or related field; MS degree is a plus.
  • Minimum of 2 years of lab experience, with expertise in HPLC and QA/QC practices.
  • Proficiency in technical writing, grammar, and composition.
  • Understanding of GMP/cGMP/GLP regulations and quality system requirements.
  • Excellent communication skills, both written and verbal, with the ability to collaborate effectively in cross-functional teams.
  • Strong time management skills and attention to detail, capable of managing multiple projects in a fast-paced environment.
  • Proficiency in Microsoft Word, PowerPoint, and Excel.
  • Ability to work independently and collaboratively, demonstrating adaptability and initiative.


Working Conditions:

  • Standard office environment with occasional work in laboratory areas.
  • Willingness to adhere to safety protocols and wear necessary personal protective equipment.
  • Ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation.
  • May require gowning to enter laboratory areas.
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