The scientific staffing company

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.


  • 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.
Share this job:

Apply now

Similar Jobs

Medical Technologist

Indianapolis Competitive Contract

Responsibilities: Perform a variety of routine and complex medical laboratory tests using automated and manual procedures. Utilize laboratory...

Microbiologist II

Indianapolis $50,000 - $80,000 Contract

Responsibilities:  Design and conduct microbiological experiments and research projects to address specific scientific questions or busines...

Research Assistant

Indianapolis $40,000-$50,000 Contract

Job Responsibilities: Assist in the execution of experimental protocols and procedures under the guidance of senior researchers. Perform data...

Microbiologist I/II

Indianapolis $50,000-$60,000 Contract

Job Responsibilities: Perform aseptic techniques for the cultivation and maintenance of microbial cultures. Conduct microbial assays, includin...

Medical Technologist II - Core Lab

Indianapolis $60,000k - $80,000 p/h Contract

Job Responsibilities: This position is responsible for providing services of both a technical and non-technical nature in the laboratory s...